Olympus WA69320LRecalls & reported problems
OLYMPUS Winter & Ibe GmbH · Jaws insert "HICURA", 5 x 430, CroceOlmi, monopolar · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04042761079280), received between Jun 15, 2021 and Feb 2, 2026 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Break” (2 reports).
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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break2
- Detachment of Device or Device Component1
- Fracture1
- Material Fragmentation1
- Material Twisted/Bent1
- Mechanical Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryFeb 2, 2026Break; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A LAPAROSCOPIC CYSTECTOMY, APPROXIMATELY 5 MM OF THE LOWER PORTION OF THE TIP OF THIS FORCEPS WAS DAMAGED AND FELL OFF INTO THE ABDOMINAL LUMEN. OTHER FORCEPS WAS USED TO SUCCESSFULLY RETRIEVE THE PART THAT FELL OFF. THE PROCEDURE WAS THEN COMPLETED. THERE WERE NO FURTHER REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24240650 ↗MalfunctionMay 30, 2023Material Twisted/Bent; Material Twisted/Bent
THE CUSTOMER REPORTED TO OLYMPUS, THE TIP OF THE HANDLE IS BENT ON THE JAWS INSERT. THE ISSUE WAS FOUND DURING AN ESOPHAGECTOMY RECONSTRUCTION (UNDER LONGITUDINAL MIRROR) PROCEDURE. THE PROCEDURE WAS COMPLETED USING A DIFFERENT DEVICE OF THE SAME MODEL NUMBER. THE DEVICE WAS INSPECTED PRIOR TO USE AND NO PROBLEMS WERE OBSERVED. THERE WAS NO DELAY AND NO REPORTS OF PATIENT HARM. THE TIME AND FURTHER DETAILS OF THE EVENT ARE UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17021168 ↗MalfunctionJun 15, 2021Break; Fracture; Material Fragmentation; Mechanical Problem; Break; Fracture; Material Fragmentation; Mechanical Problem
OLYMPUS WAS INFORMED THAT DURING AN UNSPECIFIED PROCEDURE, ONE JAWS DISTAL END BROKE WHEN TAKING AND CLAMPING THE TISSUE AND A FRAGMENT FELL INTO THE PATIENT'S BODY CAVITY. HOWEVER, NO FRAGMENT REMAINED INSIDE THE PATIENT SINCE IT WAS REPORTEDLY RETRIEVED. THE INTENDED PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SIMILAR DEVICE AND THERE WAS NO REPORT ABOUT AN ADVERSE EVENT OR PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11997463 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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