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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

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 3 reportsJul 2026: 0 reportsAug 2026: 1 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520263
Last 36 months. The most recent month may be incomplete.

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

All Endoscope, Ac-Powered And Accessories devices →

Sources and updates

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