Olympus A4674ARecalls & reported problems
OLYMPUS Winter & Ibe GmbH · Telescope, 3 mm, 30°, wideangle, autoclavable · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Olympus rigid endoscope telescope is used in endoscopic procedures. Of its 170 reports, most describe breaks, chipped lenses, and parts detaching, and the reports mention no deaths or injuries. The telescope has 1 open recall, from April 2024, over a skipped leak test that could let liquid into the eyepiece. Reports fell over the past 12 months, with 28 compared with 64 in the year before.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 169
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 169 adverse event reports that list this exact device (DI 04042761006361), received between Dec 28, 2022 and Jun 30, 2026 — classified as 169 malfunctions.
The most frequently reported specific device problem is “Break” (99 reports).
1 FDA recall record name this device's identifier, 1 still open.
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
Recalls naming this device
- Apr 18, 2024Open, Classified
The required leakage test was not performed following of a re-work for a non-conformity. This could potentially result in liquid ingress into the eyepiece and cause a foggy image.
Z-2029-2024 · Root cause: Process change control · FDA record ↗
Most reported problems
Device problems
- Break99
- Detachment of Device or Device Component21
- Fracture9
- Crack7
- Material Twisted/Bent6
- Material Deformation4
- Optical Problem4
- Component Missing3
Patient problems
- No Clinical Signs, Symptoms or Conditions168
- Insufficient Information1
Recent adverse event reports
The 25 most recent of 169 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 30, 2026Break
THE CUSTOMER RETURNED THE RIGID ENDOSCOPE TELESCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING DEVICE ANALYSIS, THE SERVICE REPAIR TECHNICIAN IDENTIFIED A CHIPPED LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25664872 ↗MalfunctionApr 6, 2026Material Fragmentation
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID ENDOSCOPE TELESCOPE PRESENTED CHIPPED MENISCUS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24791876 ↗MalfunctionFeb 26, 2026Fracture
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID ENDOSCOPE TELESCOPE EXHIBITED FRACTURED INSERTION SECTION. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24463066 ↗MalfunctionFeb 26, 2026Break
NP ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24457032 ↗MalfunctionFeb 25, 2026Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID ENDOSCOPE TELESCOPE EXHIBITED DETACHMENT OF LIGHT GUIDE ADAPTER. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24445594 ↗MalfunctionFeb 24, 2026Break
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID ENDOSCOPE TELESCOPE HAD A BROKEN TUBE CONNECTION POINT WITH THE BODY. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24431128 ↗MalfunctionFeb 24, 2026Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID ENDOSCOPE TELESCOPE HAD A LOOSE ADHESIVE CONNECTION ON THE LIGHT GUIDE POST, AND THE POST WAS DETACHED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24428582 ↗MalfunctionFeb 23, 2026Unstable
IT WAS OBSERVED DURING DEVICE EVALUATION, THE RIGID ENDOSCOPE TELESCOPE HAD LOOSE OBJECTIVE LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24413452 ↗MalfunctionFeb 19, 2026Unstable
NO ADDITIONAL INFORMATION FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24388269 ↗MalfunctionFeb 14, 2026Break
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID ENDOSCOPE TELESCOPE EXHIBITED A BROKEN EYEPIECE CUP. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24340422 ↗MalfunctionFeb 10, 2026Break
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID ENDOSCOPE TELESCOPE EXHIBITED DAMAGED INSTRUMENT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24307527 ↗MalfunctionFeb 6, 2026Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID ENDOSCOPE TELESCOPE EXHIBITED THE FOLLOWING REPORTABLE EVENT: MISSING LIGHT GUIDE POST COVER. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24276038 ↗MalfunctionJan 15, 2026Break
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THAT THE RIGID ENDOSCOPE TELESCOPE EXHIBITED A DAMAGED OBJECTIVE WINDOW. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24079165 ↗MalfunctionJan 7, 2026Break
IT WAS REPORTED THE RIGID ENDOSCOPE TELESCOPE COMPONENT IS BROKEN. THE ISSUE WAS FOUND DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23991429 ↗MalfunctionJan 5, 2026Material Twisted/Bent
IT WAS OBSERVED DURING DEVICE EVALUATION THAT THE RIGID ENDOSCOPE TELESCOPE HAD A FAILURE OF THE INSERTION TUBE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23961137 ↗MalfunctionDec 29, 2025Break; Break
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23917280 ↗MalfunctionDec 23, 2025Crack; Crack
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23882262 ↗MalfunctionDec 16, 2025Poor Quality Image; Poor Quality Image
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID ENDOSCOPE TELESCOPE EXHIBITED EYEPIECE SECTION SCRATCHED AND LENS OF THE DISTAL END SCORCHED DISCOLORATION. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23818742 ↗MalfunctionDec 10, 2025Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THE RIGID ENDOSCOPE TELESCOPE EXHIBITED THE SHAFT SMASHED AND DING IN IT , THE ISSUE OCCURRED DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23767575 ↗MalfunctionDec 8, 2025Break; Break
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23744015 ↗MalfunctionDec 8, 2025Crack; Crack
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID ENDOSCOPE TELESCOPE EXHIBITED CRACKED OPTICAL LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23741970 ↗MalfunctionNov 26, 2025Break; Material Twisted/Bent; Break; Material Twisted/Bent
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23657112 ↗MalfunctionNov 20, 2025Material Integrity Problem; Material Integrity Problem
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23610369 ↗MalfunctionNov 19, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID ENDOSCOPE TELESCOPE EXHIBITED BROKEN OFF LENS AT LIGHT GUIDE BUNDLE INTERFACE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23595981 ↗MalfunctionNov 19, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID ENDOSCOPE TELESCOPE HAD EXHIBITED THAT THE LIGHT GUIDE EYEPIECE HAD BEEN CHIPPED AND RETAINING PIN WAS MISSING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23593789 ↗
Other Urethrotome devices
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- NA 8667961Richard Wolf GmbH · Urethrotome1 report
- n.a. 27033W-SKarl Storz GmbH & Co. KG · Urethrotome1 report
- n.a. 27068L-SKarl Storz GmbH & Co. KG · Urethrotome1 report
- USA Elite K-SBGyrus ACMI, LLC · Urethrotome1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.