Olympus WA69314MRecalls & reported problems
OLYMPUS Winter & Ibe GmbH · Jaws insert "HICURA", 5 x 330, Johann long, monopolar · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04042761079204), received between Oct 18, 2024 and Jul 29, 2026 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component2
- Break1
- Material Separation1
- Material Split, Cut or Torn1
- Material Twisted/Bent1
- Microbial Contamination of Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- Insufficient Information1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 29, 2026Material Separation; Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50066988 ↗MalfunctionJun 17, 2026Material Split, Cut or Torn
THE CUSTOMER RETURNED THE JAW INSERT TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, A LOOSE CONNECTING PIN WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: Insufficient Information
MAUDE report 25533317 ↗MalfunctionOct 17, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT DURING A COLORECTAL PROCEDURE, IT WAS FOUND THAT THE UPPER JAW OF THE FORCEPS WAS BENT, RESULTING IN A MISALIGNMENT WITH THE BOTTOM JAW. NO HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23321257 ↗MalfunctionFeb 18, 2025Break; Break
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21406701 ↗MalfunctionFeb 7, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE SUBJECT DEVICE JAWS DISLOCATED DURING AN UNSPECIFIED PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21338420 ↗MalfunctionOct 18, 2024Microbial Contamination of Device; Microbial Contamination of Device
IT WAS REPORTED THAT THE JAWS WERE NOT CLEAN. ADDITIONAL INFORMATION NOTED THAT THE CUSTOMER RECEIVED CONTAMINATED DEVICE FROM THE DEMO DEPARTMENT. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM OR IMPACT ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20482541 ↗
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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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