Olympus WA96100ARecalls & reported problems
OLYMPUS Winter & Ibe GmbH · Class 1
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04042761069663), received between Aug 7, 2025 and Mar 25, 2026 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Break” (4 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
- Break4
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 25, 2026Break; Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING DEVICE EVALUATION THE RIGID LARYNGOSCOPE DISTAL END LENS DETACHED AND BROKE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24690975 ↗MalfunctionFeb 17, 2026Break
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE FLEXIBLE SCOPE HAD A BROKEN COVER GLASS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24362344 ↗MalfunctionNov 24, 2025Break; Break
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE FLEXIBLE SCOPE EXHIBITED A BROKEN OBJECTIVE LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23631141 ↗MalfunctionAug 7, 2025Break; Break
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22738830 ↗
Other Laryngostroboscope devices
- Olympus WA96105AOLYMPUS Winter & Ibe GmbH · Laryngostroboscope2 reports
- VIDEO LARYNGOSTROBOSCOPE VLS-1070STKPentax Of America, Inc. · Laryngostroboscope2 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.