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Covidien
Model ONB5SHF · Provision · DI B504TRONB5SHF0
NLM — Laparoscope, General & Plastic Surgery, Reprocessed · Class II · 21 CFR 876.1500
UDILibrary device dossier · generated 2026-09-06 · 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 (1)
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: 1
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2019-05
0
1
2019-07
0
2
2019-09
0
1
2019-10
0
1
2021-05
0
1
2022-02
0
1
2022-06
1
1
2022-10
0
1
2022-11
0
1
2023-04
0
2
2023-11
0
1
2024-04
0
1
2024-06
0
1
2024-10
0
1
2025-03
0
1
2025-04
0
1
2025-05
0
1
2025-09
0
1
2025-10
0
1
2025-11
0
1
2025-12
0
1.33
2026-01
0
2
2026-02
0
1
2026-03
0
4.5
2026-04
0
1.6
2026-05
0
2.33
2026-06
0
1
This device (reports/month)Average device in NLM (reports/device/month)