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Olympus A4673ARecalls & reported problems

OLYMPUS Winter & Ibe GmbH · Telescope, 3 mm, 12°, autoclavable · Class 2

Adverse event reports
6
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04042761006354), received between Sep 14, 2023 and Feb 24, 2026 — classified as 6 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

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 1 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 1 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: 1 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: 1 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Break2
  • Detachment of Device or Device Component1
  • Material Twisted/Bent1
  • Pitted1
  • Unstable1

Patient problems

  • No Clinical Signs, Symptoms or Conditions6

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

  • MalfunctionFeb 24, 2026Unstable

    IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID ENDOSCOPE TELESCOPE EXHIBITED A LOOSE MENISCUS. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24437536 ↗
  • MalfunctionApr 24, 2025Break; Break

    IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID SCOPE EXHIBITED BROKENS LENS. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21905381 ↗
  • MalfunctionJun 4, 2024Break; Break

    IT WAS REPORTED THE LENS ON THE TIP END OF THE RIGID ENDOSCOPE TELESCOPE WAS BROKEN. IT IS UNKNOWN WHEN THE ISSUE OCCURRED. THERE WERE NO REPORTS OF PATIENT HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19457598 ↗
  • MalfunctionFeb 20, 2024Pitted; Pitted

    IT WAS REPORTED THAT THE RIGID ENDOSCOPE TELESCOPE'S END HAD A CHIP. THE EVENT WAS FOUND DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18738062 ↗
  • MalfunctionOct 26, 2023Material Twisted/Bent; Material Twisted/Bent

    THE CUSTOMER REPORTED THAT THE SCOPE WAS BENT. THE ISSUE WAS FOUND IN PREPARATION FOR USE IN AA THERAPEUTIC HYSTEROSCOPE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18015835 ↗
  • MalfunctionSep 14, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

    THE CUSTOMER REPORTED THAT THE LIGHT GUIDE CONNECTOR DISCONNECTION. THE ISSUE WAS FOUND DURING PREPARATION FOR USE IN AN UNSPECIFIED THERAPEUTIC PROCEDURE. THERE WERE NO REPORTS OF HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17749723 ↗

Other Urethrotome devices

All Urethrotome devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.