Olympus A64340ARecalls & reported problems
OLYMPUS Winter & Ibe GmbH · 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 04042761010269), received between Jun 1, 2023 and Jul 28, 2023 — 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.
Most reported problems
Device problems
- Break1
- Mechanical Jam1
- 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.
MalfunctionJul 28, 2023Mechanical Problem; Mechanical Problem
THE CUSTOMER REPORTED TO OLYMPUS, THE JAWS, 5 X 330 MM, DISSECTION FORCEPS, IS STUCK IN THE SET. THE ISSUE WAS FOUND DURING PREPARATION FOR USE. REPAIR IS NOT POSSIBLE DUE TO A DAMAGED INSERT MECHANISM. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17413954 ↗MalfunctionJul 27, 2023Mechanical Jam; Mechanical Jam
THE CUSTOMER REPORTED TO OLYMPUS, THE JAWS, 5 X 330 MM, DISSECTION FORCEPS, IS STUCK IN THE SET. THE ISSUE WAS FOUND DURING PREPARATION FOR USE. THE PRODUCT WAS REPAIRED ONSITE AT A LOCAL SERVICE CENTER. THERE WAS NO OTHER FAULT REPORTED. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17410424 ↗MalfunctionJun 1, 2023Break; Break
THE CUSTOMER REPORTED TO OLYMPUS THAT THE JAWS "HIQ+", 5 X 330 MM, DISSECTION FORCEPS, MARYLAND, SHORT DEVICE IS STUCK IN THE SET DURING PREPARATION FOR USE. THERE WAS NO REPORT OF PATIENT HARM OR USER INJURY ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17036130 ↗
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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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