Olympus WA64160ARecalls & reported problems
OLYMPUS Winter & Ibe GmbH · Jaws "HiQ+", 5 x 330 mm, grasping forceps, DeBakey · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04042761068826), received between Mar 18, 2024 and Mar 18, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component1
Patient problems
- 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.
InjuryMar 18, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A THERAPEUTIC RADICAL PROSTATECTOMY, PART OF THE UPPER TIP OF THE GRASPING FORCEPS CAME OFF AND FELL INTO THE BODY. THE FALLEN PIECES HAVE BEEN RECOVERED INTRAPERITONEALLY, WITHIN 30 SECONDS WITH A SEPARATE PAIR OF SURGICAL FORCEPS AND INTRAPERITONEAL LAVAGE PERFORMED. NO SHARP EDGES REPORTED ON THE FALLEN DEVICE. THE PROCEDURE WAS COMPLETED BY REPLACING WITH ANOTHER FORCEPS WITHOUT ADDITIONAL ANESTHESIA. THERE WAS NO DELAY AND NO HEALTH DAMAGE REPORTED. THE DEVICE WAS INSPECTED PRIOR TO USE AND FOUND TO HAVE NO PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18921521 ↗
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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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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