Covidien ONB5SHF (UDI 00810041639073)Recalls & reported problems
Provision · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00810041639073), received between Nov 18, 2022 and Nov 18, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Leak/Splash” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Leak/Splash1
- Material Split, Cut or Torn1
- Noise, Audible1
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 18, 2022Leak/Splash; Noise, Audible; Material Split, Cut or Torn; Leak/Splash; Noise, Audible; Material Split, Cut or Torn
ACCORDING TO THE REPORTER, INTRAOPERATIVELY, AIR LEAKAGE WAS NOTED. THERE WAS A CRACK IN THE SEAL. THE DEVICE EVEN STARTED MAKING A NOISE. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 15826240 ↗
Other Laparoscope, General & Plastic Surgery, Reprocessed devices
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- N/AStryker Sustainability Solutions, Inc. · LAPAROSCOPE, GENERAL & PLASTIC SURGERY, REPROCESSED1 recall16 reports
- N/AStryker Sustainability Solutions, Inc. · LAPAROSCOPE, GENERAL & PLASTIC SURGERY, REPROCESSED1 recall3 reports
- N/AStryker Sustainability Solutions, Inc. · LAPAROSCOPE, GENERAL & PLASTIC SURGERY, REPROCESSED1 recall2 reports
- N/AStryker Sustainability Solutions, Inc. · LAPAROSCOPE, GENERAL & PLASTIC SURGERY, REPROCESSED1 recall0 reports
- N/AStryker Sustainability Solutions, Inc. · LAPAROSCOPE, GENERAL & PLASTIC SURGERY, REPROCESSED1 recall0 reports
- N/AStryker Sustainability Solutions, Inc. · LAPAROSCOPE, GENERAL & PLASTIC SURGERY, REPROCESSED1 recall0 reports
- N/AStryker Sustainability Solutions, Inc. · LAPAROSCOPE, GENERAL & PLASTIC SURGERY, REPROCESSED13 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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