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Monarch Bronchoscope

Model MBR-000211-A · Auris Health, Inc. · DI 10810068810865

EOQ — Bronchoscope (Flexible Or Rigid) · Class II · 21 CFR 874.4680

UDILibrary device dossier · generated 2026-09-14 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (4)

InitiatedRecall #ClassStatusReasonLink basis
2026-01-21Z-1383-2026Class IIOpen, ClassifiedDevice for bronchoscopic visualization, patient airway access has software issue: if application restarts after patient-side selection, prior to bronchoscope loading, application will re-initialize to patient-left position; and if right position was previously selected, this may lead to unanticipated robotic arm positioning toward patient-left, may result in contact with patient/endotracheal tube.k number procode
2023-10-18Z-0448-2024Class IIOpen, ClassifiedTheir is the potential that software issues may result in flipped image of the virtual Bronchoscope view.k number procode
2023-10-18Z-0449-2024Class IIOpen, ClassifiedTheir is the potential that software issues may result in flipped image of the virtual Bronchoscope view.k number procode
2023-10-18Z-0450-2024Class IIOpen, ClassifiedTheir is the potential that software issues may result in flipped image of the virtual Bronchoscope view.k number procode

Adverse-event reports — MAUDE (10)

Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.

Malfunction: 7 · Injury: 3

112234452019-01: 0 reports for this device; peer average 1.2/device2019-02: 0 reports for this device; peer average 1.5/device2019-03: 0 reports for this device; peer average 6.89/device2019-04: 0 reports for this device; peer average 44.75/device2019-05: 0 reports for this device; peer average 4/device2019-06: 0 reports for this device; peer average 3/device2019-07: 0 reports for this device; peer average 2.54/device2019-08: 0 reports for this device; peer average 4.78/device2019-09: 0 reports for this device; peer average 2.78/device2019-10: 0 reports for this device; peer average 2.57/device2019-11: 0 reports for this device; peer average 2.4/device2019-12: 0 reports for this device; peer average 4.25/device2020-01: 0 reports for this device; peer average 2.92/device2020-02: 0 reports for this device; peer average 6.2/device2020-03: 0 reports for this device; peer average 2.33/device2020-04: 0 reports for this device; peer average 4.31/device2020-05: 0 reports for this device; peer average 2.93/device2020-06: 0 reports for this device; peer average 4.24/device2020-07: 0 reports for this device; peer average 4.65/device2020-08: 0 reports for this device; peer average 4.5/device2020-09: 0 reports for this device; peer average 3.76/device2020-10: 0 reports for this device; peer average 3.91/device2020-11: 0 reports for this device; peer average 4.52/device2020-12: 0 reports for this device; peer average 6.57/device2021-01: 0 reports for this device; peer average 4.39/device2021-02: 0 reports for this device; peer average 4.04/device2021-03: 0 reports for this device; peer average 5.57/device2021-04: 0 reports for this device; peer average 4.75/device2021-05: 0 reports for this device; peer average 5.1/device2021-06: 0 reports for this device; peer average 4.02/device2021-07: 0 reports for this device; peer average 3.22/device2021-08: 0 reports for this device; peer average 4.9/device2021-09: 0 reports for this device; peer average 4.18/device2021-10: 0 reports for this device; peer average 4.75/device2021-11: 0 reports for this device; peer average 3.93/device2021-12: 0 reports for this device; peer average 4.87/device2022-01: 0 reports for this device; peer average 4.98/device2022-02: 0 reports for this device; peer average 4.54/device2022-03: 0 reports for this device; peer average 6.65/device2022-04: 0 reports for this device; peer average 6.56/device2022-05: 0 reports for this device; peer average 5.72/device2022-06: 0 reports for this device; peer average 6.05/device2022-07: 0 reports for this device; peer average 6.22/device2022-08: 0 reports for this device; peer average 5.78/device2022-09: 1 reports for this device; peer average 5.19/device2022-10: 0 reports for this device; peer average 5.56/device2022-11: 0 reports for this device; peer average 5.65/device2022-12: 0 reports for this device; peer average 5.77/device2023-01: 0 reports for this device; peer average 8/device2023-02: 0 reports for this device; peer average 5.67/device2023-03: 0 reports for this device; peer average 7.22/device2023-04: 0 reports for this device; peer average 5.99/device2023-05: 0 reports for this device; peer average 6.6/device2023-06: 0 reports for this device; peer average 6.31/device2023-07: 0 reports for this device; peer average 6.17/device2023-08: 2 reports for this device; peer average 7.54/device2023-09: 0 reports for this device; peer average 6.8/device2023-10: 0 reports for this device; peer average 6.71/device2023-11: 0 reports for this device; peer average 7.17/device2023-12: 0 reports for this device; peer average 7.04/device2024-01: 1 reports for this device; peer average 6.36/device2024-02: 0 reports for this device; peer average 6.05/device2024-03: 0 reports for this device; peer average 7.21/device2024-04: 0 reports for this device; peer average 6.19/device2024-05: 0 reports for this device; peer average 6.2/device2024-06: 0 reports for this device; peer average 7.13/device2024-07: 0 reports for this device; peer average 6.06/device2024-08: 0 reports for this device; peer average 7.7/device2024-09: 0 reports for this device; peer average 6.97/device2024-10: 0 reports for this device; peer average 8.15/device2024-11: 0 reports for this device; peer average 10.86/device2024-12: 0 reports for this device; peer average 4.17/device2025-01: 0 reports for this device; peer average 4.16/device2025-02: 0 reports for this device; peer average 3.73/device2025-03: 0 reports for this device; peer average 4.21/device2025-04: 0 reports for this device; peer average 4.31/device2025-05: 0 reports for this device; peer average 4.93/device2025-06: 0 reports for this device; peer average 4.86/device2025-07: 0 reports for this device; peer average 5.79/device2025-08: 0 reports for this device; peer average 5.13/device2025-09: 0 reports for this device; peer average 4.38/device2025-10: 4 reports for this device; peer average 5.19/device2025-11: 0 reports for this device; peer average 6.62/device2025-12: 0 reports for this device; peer average 10.31/device2026-01: 1 reports for this device; peer average 8.47/device2026-02: 0 reports for this device; peer average 6.48/device2026-03: 0 reports for this device; peer average 6.61/device2026-04: 0 reports for this device; peer average 8.85/device2026-05: 1 reports for this device; peer average 9.34/device2026-06: 0 reports for this device; peer average 8.3/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101.2
2019-0201.5
2019-0306.89
2019-04044.75
2019-0504
2019-0603
2019-0702.54
2019-0804.78
2019-0902.78
2019-1002.57
2019-1102.4
2019-1204.25
2020-0102.92
2020-0206.2
2020-0302.33
2020-0404.31
2020-0502.93
2020-0604.24
2020-0704.65
2020-0804.5
2020-0903.76
2020-1003.91
2020-1104.52
2020-1206.57
2021-0104.39
2021-0204.04
2021-0305.57
2021-0404.75
2021-0505.1
2021-0604.02
2021-0703.22
2021-0804.9
2021-0904.18
2021-1004.75
2021-1103.93
2021-1204.87
2022-0104.98
2022-0204.54
2022-0306.65
2022-0406.56
2022-0505.72
2022-0606.05
2022-0706.22
2022-0805.78
2022-0915.19
2022-1005.56
2022-1105.65
2022-1205.77
2023-0108
2023-0205.67
2023-0307.22
2023-0405.99
2023-0506.6
2023-0606.31
2023-0706.17
2023-0827.54
2023-0906.8
2023-1006.71
2023-1107.17
2023-1207.04
2024-0116.36
2024-0206.05
2024-0307.21
2024-0406.19
2024-0506.2
2024-0607.13
2024-0706.06
2024-0807.7
2024-0906.97
2024-1008.15
2024-11010.86
2024-1204.17
2025-0104.16
2025-0203.73
2025-0304.21
2025-0404.31
2025-0504.93
2025-0604.86
2025-0705.79
2025-0805.13
2025-0904.38
2025-1045.19
2025-1106.62
2025-12010.31
2026-0118.47
2026-0206.48
2026-0306.61
2026-0408.85
2026-0519.34
2026-0608.3
This device (reports/month)Average device in EOQ (reports/device/month)

Regulatory clearances

  • K193534 SESE 2020-04-15 (k number procode)

Predicate lineage

K193534 — cites (transitively): K173760 (d1), K071530 (d2), K151376 (d2), K152319 (d2), K162611 (d2), K834402 (d2), K860582 (d2), K925392 (d2), K944650 (d2), K962555 (d2), K102604 (d3), K052480 (d3), K121959 (d3), K904667 (d3), K914181 (d3), K092365 (d4), K051645 (d4), K061313 (d4), K062049 (d4), K100584 (d4) — cited as predicate by K203614, K211493, K213334, K231473

Lineage extracted from public 510(k) summary text (heuristic).

Manufacturer compliance record — Auris Health, Inc.

  • NAI 2020-02-07 Auris Health Inc. · 0 citations
  • NAI 2020-02-06 AURIS HEALTH INC · 0 citations
  • NAI 2020-02-06 AURIS HEALTH INC · 0 citations
  • NAI 2017-07-11 Auris Health Inc. · 0 citations
  • NAI 2017-02-13 Auris Health Inc. · 0 citations