Olympus A60200ARecalls & reported problems
OLYMPUS Winter & Ibe GmbH · Handle "HiQ+", Ergo S, ratchet · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04042761009782), received between Jul 28, 2020 and Jul 28, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Component Missing” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Component Missing1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 28, 2020Component Missing; Component Missing
OLYMPUS WAS INFORMED THAT DURING AN UNSPECIFIED THERAPEUTIC PROCEDURE AT AN UNKNOWN DATE, THE SCREW OF THE SUBJECT HANDLE WAS MISSING AFTER THE SUBJECT HANDLE WAS USED IN COMBINATION WITH A FORCEPS. SINCE THE SCREW WAS NOT DETECTED ANYWHERE, IT IS ASSUMED THAT IT MAY HAVE FALLEN INTO THE PATIENT DURING THE PROCEDURE. HOWEVER, THE INTENDED PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE SAME SET OF EQUIPMENT AND THERE WAS NO REPORT ABOUT AN ADVERSE EVENT OR PATIENT INJURY. AN X-RAY IS PLANNED TO CONFIRM THE PRESENCE OF ANY RESIDUE IN THE PATIENT¿S BODY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10331822 ↗
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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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