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Raptor
Model 00711177 · US Endoscopy · DI 00724995183653
OCZ — Endoscopic Grasping/Cutting Instrument, Non-Powered · Class II · 21 CFR 876.1500
PTS — Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt · Class II · 21 CFR 876.1500
UDILibrary device dossier · generated 2026-09-13 · 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 (69)
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: 69
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2019-01
0
1
2019-02
0
1.4
2019-03
0
1.5
2019-04
1
1.13
2019-05
0
1.33
2019-06
0
1.17
2019-07
0
1.5
2019-08
0
1
2019-09
0
1
2019-10
0
1.86
2019-11
0
1.33
2019-12
0
1
2020-01
0
1.25
2020-02
0
2.17
2020-03
0
2
2020-04
0
3
2020-05
1
1
2020-06
0
2.5
2020-07
2
1.33
2020-09
0
1.63
2020-10
0
2
2020-11
0
1.5
2020-12
0
1.2
2021-01
0
1
2021-02
0
2
2021-03
0
1.75
2021-04
0
2
2021-05
0
2
2021-06
2
2
2021-07
1
1.2
2021-08
0
1.5
2021-09
0
1
2021-10
1
1.33
2021-11
0
2.25
2021-12
0
1
2022-02
0
1.75
2022-03
2
2.5
2022-04
2
1.67
2022-05
3
2.5
2022-06
0
3.5
2022-07
0
2.67
2022-08
0
1.5
2022-09
1
1.75
2022-10
0
1.8
2022-11
0
2
2022-12
0
1.88
2023-01
0
1.75
2023-02
0
2
2023-03
0
2.5
2023-04
1
1.44
2023-05
1
1
2023-06
1
1
2023-07
1
1
2023-08
0
1
2023-09
0
4.33
2023-10
0
1.67
2023-11
2
1.5
2023-12
1
1.36
2024-01
0
1.75
2024-02
0
1.67
2024-03
0
2
2024-04
2
1.6
2024-05
0
1.25
2024-06
1
1.17
2024-07
1
1.22
2024-08
0
1.5
2024-09
2
1.6
2024-10
3
1.9
2024-11
2
5.55
2024-12
0
8.83
2025-01
0
1.5
2025-02
3
1.73
2025-03
6
2.91
2025-04
0
2
2025-05
0
16.67
2025-06
0
1
2025-07
0
4.33
2025-08
0
2
2025-09
0
1.86
2025-11
5
3.08
2025-12
3
2.2
2026-01
6
4
2026-02
0
2.5
2026-03
0
2.17
2026-04
11
6.25
2026-05
0
2.14
2026-06
1
2
This device (reports/month)Average device in OCZ, PTS (reports/device/month)