Olympus A20913ARecalls & reported problems
OLYMPUS Winter & Ibe GmbH · Cystoscope sheath, 21Fr. · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- 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 04042761020251), received between Jun 30, 2026 and Aug 25, 2026 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 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
- Detachment of Device or Device Component3
- Break2
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.
MalfunctionAug 25, 2026Break; Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50437685 ↗MalfunctionJun 30, 2026Break
IT WAS REPORTED THE CYSTOSCOPE SHEATH STOPCOCK BROKE OFF DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25668493 ↗MalfunctionJun 30, 2026Detachment of Device or Device Component
IT WAS REPORTED THE CYSTOSCOPE SHEATH STOPCOCK CAME OFF DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25667097 ↗MalfunctionJun 30, 2026Detachment of Device or Device Component
IT WAS REPORTED THE CYSTOSCOPE SHEATH STOPCOCK CAME OFF DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25666247 ↗
Other Endoscope, Ac-Powered And Accessories devices
- Olympus WA22810AOLYMPUS Winter & Ibe GmbH · Endoscope, Ac-Powered And Accessories2 recalls8 reports
- Olympus A22201DOLYMPUS Winter & Ibe GmbH · Endoscope, Ac-Powered And Accessories1 recall7 reports
- 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 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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