ENT MR8
Model 1847ATTSS · MEDTRONIC POWERED SURGICAL SOLUTIONS · DI 00763000356965
ERL — Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece · Class II · 21 CFR 874.4250
UDILibrary device dossier · generated 2026-09-11 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.
Recall history (0)
No recalls linked in the loaded window.
Adverse-event reports — MAUDE (88)
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: 88
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 4.2 |
| 2019-02 | 0 | 3.58 |
| 2019-03 | 0 | 6.27 |
| 2019-04 | 0 | 5.47 |
| 2019-05 | 0 | 3.92 |
| 2019-06 | 0 | 4.13 |
| 2019-07 | 0 | 4.17 |
| 2019-08 | 0 | 5.32 |
| 2019-09 | 0 | 4.17 |
| 2019-10 | 0 | 4.24 |
| 2019-11 | 0 | 5.24 |
| 2019-12 | 0 | 5.06 |
| 2020-01 | 0 | 4.4 |
| 2020-02 | 0 | 3.92 |
| 2020-03 | 0 | 4.79 |
| 2020-04 | 0 | 4.51 |
| 2020-05 | 0 | 2.98 |
| 2020-06 | 0 | 5.68 |
| 2020-07 | 0 | 5.4 |
| 2020-08 | 0 | 4.57 |
| 2020-09 | 0 | 4.43 |
| 2020-10 | 0 | 5.14 |
| 2020-11 | 0 | 4.88 |
| 2020-12 | 0 | 5.08 |
| 2021-01 | 0 | 4.86 |
| 2021-02 | 0 | 5.1 |
| 2021-03 | 0 | 5.73 |
| 2021-04 | 0 | 4.56 |
| 2021-05 | 0 | 4.56 |
| 2021-06 | 0 | 5.43 |
| 2021-07 | 0 | 4.49 |
| 2021-08 | 0 | 4.87 |
| 2021-09 | 0 | 3.93 |
| 2021-10 | 0 | 3.19 |
| 2021-11 | 0 | 4.08 |
| 2021-12 | 0 | 3.67 |
| 2022-01 | 0 | 3.52 |
| 2022-02 | 0 | 3.15 |
| 2022-03 | 0 | 3.37 |
| 2022-04 | 0 | 3.75 |
| 2022-05 | 0 | 2.97 |
| 2022-06 | 0 | 4.16 |
| 2022-07 | 0 | 4.17 |
| 2022-08 | 0 | 4.26 |
| 2022-09 | 0 | 3.72 |
| 2022-10 | 0 | 4.13 |
| 2022-11 | 0 | 4.3 |
| 2022-12 | 0 | 4.24 |
| 2023-01 | 0 | 3.42 |
| 2023-02 | 0 | 3.95 |
| 2023-03 | 0 | 4.6 |
| 2023-04 | 0 | 4 |
| 2023-05 | 0 | 5.03 |
| 2023-06 | 0 | 3.99 |
| 2023-07 | 0 | 4.33 |
| 2023-08 | 0 | 3.73 |
| 2023-09 | 0 | 3.85 |
| 2023-10 | 0 | 3.6 |
| 2023-11 | 0 | 3.86 |
| 2023-12 | 0 | 3.34 |
| 2024-01 | 0 | 4.05 |
| 2024-02 | 0 | 4.64 |
| 2024-03 | 0 | 4.32 |
| 2024-04 | 0 | 4.26 |
| 2024-05 | 0 | 3.3 |
| 2024-06 | 0 | 3.43 |
| 2024-07 | 0 | 3.6 |
| 2024-08 | 3 | 3.6 |
| 2024-09 | 1 | 4.95 |
| 2024-10 | 0 | 4.01 |
| 2024-11 | 0 | 3.64 |
| 2024-12 | 0 | 3.46 |
| 2025-01 | 1 | 2.95 |
| 2025-02 | 1 | 6.82 |
| 2025-03 | 4 | 4.95 |
| 2025-04 | 0 | 3.08 |
| 2025-05 | 2 | 4.42 |
| 2025-06 | 1 | 3.56 |
| 2025-07 | 0 | 3.98 |
| 2025-08 | 0 | 3.5 |
| 2025-09 | 1 | 3.1 |
| 2025-10 | 0 | 3.8 |
| 2025-11 | 0 | 3.27 |
| 2025-12 | 1 | 3.46 |
| 2026-01 | 0 | 2.62 |
| 2026-02 | 0 | 3.38 |
| 2026-03 | 8 | 3.6 |
| 2026-04 | 18 | 5.25 |
| 2026-05 | 10 | 3.94 |
| 2026-06 | 37 | 4.1 |
Regulatory clearances
- None linked in the loaded window.
Predicate lineage
K183515 — cites (transitively): K163182 (d1), K163565 (d1), K170312 (d1), K020069 (d2), K072315 (d2), K090112 (d2), K870157 (d2), K081475 (d2), K012457 (d2), K121264 (d2), K081277 (d3) — cited as predicate by K183644, K202552, K213454, K252662
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — MEDTRONIC POWERED SURGICAL SOLUTIONS
- NAI 2024-12-05 Medtronic Powered Surgical Solutions · 0 citations