Olympus WB991001Recalls & reported problems
OLYMPUS Winter & Ibe GmbH · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04042768910012), received between Nov 17, 2020 and Nov 17, 2020 — classified as 1 injury.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Necrosis1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
OLYMPUS WAS INFORMED THAT DURING AN UNSPECIFIED PALATE SURGERY AT AN UNKNOWN DATE, THE PATIENT SUSTAINED NECROSIS ON THE TISSUE. NO FURTHER INFORMATION WAS PROVIDED SO FAR, BUT THERE WAS NO REPORT OF A MALFUNCTION FOR ANY OF THE OLYMPUS MEDICAL DEVICES.
Patient problems: Necrosis
MAUDE report 10851924 ↗
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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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