Olympus A64810ARecalls & reported problems
OLYMPUS Winter & Ibe GmbH · Jaws "HiQ+", 5 x 330 mm, scissors, Metzenbaum · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 04042761010320), received between Mar 1, 2023 and Aug 28, 2026 — classified as 8 malfunctions.
The most frequently reported specific device problem is “Break” (5 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break5
- Mechanical Problem2
- Difficult to Open or Close1
Patient problems
- No Clinical Signs, Symptoms or Conditions8
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 28, 2026Mechanical Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50507289 ↗MalfunctionJun 9, 2025Break; Break
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22170651 ↗MalfunctionMay 12, 2025Difficult to Open or Close; Difficult to Open or Close
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE HAND INSTRUMENT SET WITH SCISSORS EXHIBITED A DEFORMATION IN THE BLADE SURFACE OF THE PRODUCT SCISSORS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22006238 ↗MalfunctionJan 31, 2025Break; Break
IT WAS REPORTED THAT THE JAWS WERE BROKEN. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21286471 ↗MalfunctionAug 16, 2023Break; Break
ADDITIONAL INFORMATION WAS PROVIDED. THE INTENDED PROCEDURE WAS FOR A THERAPEUTIC LAPAROSCOPIC CHOLECYSTECTOMY. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING ANOTHER SIMILAR DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17560445 ↗MalfunctionAug 12, 2023Mechanical Problem; Mechanical Problem
THE INTENDED PROCEDURE WAS LAPAROSCOPIC CHOLECYSTECTOMY. THE INTENDED PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17537841 ↗MalfunctionMar 30, 2023Break; Break
OLYMPUS WAS INFORMED THE CUSTOMER HIQ+, METZENBAUM GRASPING SCISSORS HAS "BROKEN PARTS OF THE JAWS". MECHANICAL MALFUNCTION DURING ASSEMBLY BY EXCESSIVE FORCE. THE CUSTOMER REPORTED PROBLEM WAS FOUND AT PREPARATION FOR USE. NO PROCEDURE INVOLVED AND NO INJURY OR IMPACT TO PATIENT OR OTHER WAS REPORTED TO OLYMPUS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16645117 ↗MalfunctionMar 1, 2023Break; Break
OLYMPUS WAS INFORMED THE CUSTOMER HIQ+ METZENBAUM SCISSORS HAS ¿BROKEN JAWS.¿ THE JAWS BROKE MECHANICALLY DURING REPROCESSING. THE DEVICE FELL TO THE GROUND AND THE NURSE ACCIDENTALLY STEPPED ON THE DEVICE. NO DEATH OR INJURY AND NO IMPACT TO PATIENT OR OTHER WAS REPORTED. THE DEVICE WAS DISPOSED AND WILL NOT BE RETURNED TO OLYMPUS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16457997 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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