Olympus A4827Recalls & reported problems
OLYMPUS Winter & Ibe GmbH · Class 1
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 04042761006903), received between Nov 5, 2024 and Nov 5, 2024 — classified as 1 malfunction.
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 5, 2024Break; Break
IT WAS REPORTED, THAT THE TEETH ON GRASPERS (GRASPING FORCEP) BROKE. THE ISSUE OCCURRED IN THE MIDDLE OF A DIAGNOSTIC HYSTEROSCOPY INTRAUTERINE DEVICE REMOVAL PROCEDURE. THE PROCEDURE WAS COMPLETED USING THE SIMILAR DEVICE, WITH NO DELAY. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20614602 ↗
Other Hysteroscope Accessories devices
- Olympus A4832OLYMPUS Winter & Ibe GmbH · Hysteroscope Accessories12 reports
- OMNI OMNI-S-001Hologic, Inc. · Hysteroscope accessories8 reports
- Olympus A4829OLYMPUS Winter & Ibe GmbH · Hysteroscope Accessories8 reports
- Olympus A4825OLYMPUS Winter & Ibe GmbH · Hysteroscope Accessories8 reports
- CLICKLINE 26312Karl Storz GmbH & Co. KG · Hysteroscope accessories6 reports
- n.a. 26153BIKarl Storz GmbH & Co. KG · Hysteroscope accessories3 reports
- OMNI OMNI-G-001Hologic, Inc. · Hysteroscope accessories1 report
- NA M006550340Boston Scientific Corporation · Hysteroscope accessories1 report
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.
How reports and recalls are matched · Editorial policy · Report an error on this page