Olympus A20918ARecalls & reported problems
OLYMPUS Winter & Ibe GmbH · Cystoscope, 30°, 14 Fr. x 230 mm, 7 Fr. channel, straight ocular · Class 2
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04042761030069), received between Oct 31, 2025 and Apr 10, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (2 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
- Break2
- Unstable1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 10, 2026Break
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID CYSTOSCOPE HAD A CHIPPED LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24838852 ↗MalfunctionFeb 26, 2026Unstable
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID SCOPE HAD LOOSE RING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24457538 ↗MalfunctionOct 31, 2025Break; Break
IT WAS REPORTED THAT THE SUBJECT DEVICE HAD FIBER AND GLASS BREAKAGE IN THE SYSTEM. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23436214 ↗
Other Endoscope, Ac-Powered And Accessories devices
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- Olympus A22205DOLYMPUS Winter & Ibe GmbH · Endoscope, Ac-Powered And Accessories1 recall5 reports
- Olympus A22257COLYMPUS Winter & Ibe GmbH · Endoscope, Ac-Powered And Accessories1 recall1 report
- Olympus A22207COLYMPUS Winter & Ibe GmbH · Endoscope, Ac-Powered And Accessories1 recall1 report
- Olympus A22221COLYMPUS Winter & Ibe GmbH · Endoscope, Ac-Powered And Accessories1 recall1 report
- Olympus A22222COLYMPUS Winter & Ibe GmbH · Endoscope, Ac-Powered And Accessories1 recall0 reports
- Olympus A22231DOLYMPUS Winter & Ibe GmbH · Endoscope, Ac-Powered And Accessories1 recall0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.