Olympus WA69332MRecalls & reported problems
OLYMPUS Winter & Ibe GmbH · Jaws insert "HICURA", 5 x 330, Clinching, monopolar · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04042761079396), received between Dec 12, 2024 and Dec 27, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (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
- Break1
- Material Integrity Problem1
- Material Separation1
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.
MalfunctionDec 27, 2024Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THE HICURA JAWS INSERT HAD DAMAGED JAWS. THE JAWS DO NOT GRASP TISSUE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21027150 ↗MalfunctionDec 27, 2024Break; Break
IT WAS REPORTED THE HICURA JAWS INSERT HAD DAMAGED JAWS. THE JAWS DO NOT GRASP TISSUE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21026741 ↗MalfunctionDec 12, 2024Material Separation; Material Separation
IT WAS REPORTED THE MONOPOLAR CLINCHING JAWS INSERT'S JAWS CAME APART. THE ISSUE OCCURRED DURING A LAPAROSCOPIC SURGERY PROCEDURE. THE PROCEDURE WAS COMPLETED AS PLANNED, USING ANOTHER SET OF INSTRUMENTS. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20914073 ↗
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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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