Olympus A20919ARecalls & reported problems
OLYMPUS Winter & Ibe GmbH · Cystoscope, 30°, 17 Fr. x 225 mm, 9 Fr. channel, ocular angle 45° · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04042761030052), received between Jan 18, 2023 and Apr 13, 2026 — classified as 7 malfunctions.
The most frequently reported specific device problem is “Break” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break3
- Degraded2
- Detachment of Device or Device Component2
- Optical Problem1
- Peeled/Delaminated1
Patient problems
- No Clinical Signs, Symptoms or Conditions7
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 13, 2026Peeled/Delaminated
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID SCOPE HAD AURUM PLATING DISTAL END PEELED OFF. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24855961 ↗MalfunctionMar 26, 2026Degraded
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID SCOPE HAD WORN DISTAL TERMINAL. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24698357 ↗MalfunctionMar 25, 2026Break; Degraded; Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID CYSTOSCOPE EXHIBITED CHIPPED AND BROKEN INNER BARREL ASSEMBLY, AND EXTREMELY WORN DISTAL TERMINAL. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24686307 ↗MalfunctionDec 11, 2025Break; Break
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID SCOPE EXHIBITED A DAMAGED EYEPIECE FUNNEL. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23782766 ↗MalfunctionAug 6, 2025Optical Problem; Optical Problem
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE EXHIBITED THE LIGHT GUIDE FIBERS ARE BROKEN. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22728572 ↗MalfunctionJan 23, 2025Break; Break
IT WAS REPORTED, THE LOCK OF THE RIGID SCOPE WAS BROKEN. THE ISSUE OCCURRED DURING MAINTENANCE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21226496 ↗MalfunctionJan 18, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
OLYMPUS (OMSC) WAS INFORMED THAT THE CUSTOMER SINGLE CHANNEL, OCULAR ANGLE RIGID CYSTOSCOPE WAS RETURNED TO THE OLYMPUS SERVICE CENTER FOR A REPORTED ¿CLOUDY LENS¿ WHICH WAS FOUND AT AN UNSPECIFIED EVENT. DURING THE SERVICE INSPECTION, THE STOPCOCK FIXING SCREW WAS FOUND MISSING. NO DEATH OR INJURY AND NO IMPACT TO PATIENT OR OTHER WAS REPORTED TO OLYMPUS. THIS REPORT IS BEING SUBMITTED TO CAPTURE THE BROKEN, MISSING COMPONENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16199989 ↗
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 A22221COLYMPUS Winter & Ibe GmbH · Endoscope, Ac-Powered And Accessories1 recall1 report
- 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 A22203COLYMPUS Winter & Ibe GmbH · Endoscope, Ac-Powered And Accessories1 recall0 reports
- Olympus A22223COLYMPUS 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 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.
How reports and recalls are matched · Editorial policy · Report an error on this page