Olympus WA2T430ARecalls & reported problems
OLYMPUS Winter & Ibe GmbH · Telescope "OES ELITE", 4 mm, 30°, HD, autoclavable · Class 2
Quick summary
This Olympus OES Elite hysteroscope telescope has 783 FDA reports, including 777 malfunctions, 6 injuries and no deaths. Most reports describe the telescope breaking or chipping, with parts detaching, and a few injuries mention bleeding or lacerations. There are no recalls naming this device.
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
- 783
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 783 adverse event reports that list this exact device (DI 04042761077545), received between Oct 27, 2021 and Aug 11, 2026 — classified as 6 injuries, 777 malfunctions.
The most frequently reported specific device problem is “Break” (512 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
- Break512
- Detachment of Device or Device Component115
- Crack52
- Poor Quality Image24
- Component Missing20
- Loose or Intermittent Connection18
- Material Fragmentation11
- Material Twisted/Bent11
Patient problems
- No Clinical Signs, Symptoms or Conditions779
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Hemorrhage/Blood Loss/Bleeding2
- Ecchymosis1
- Laceration(s)1
- Perforation1
- Rupture1
- Unspecified Gastrointestinal Problem1
Recent adverse event reports
The 25 most recent of 783 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 11, 2026Break
The customer returned the Rigid Scope to the service center for a separate issue. During the device analysis, the service repair technician indicates that a chipped lens on the cover glass was found. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50208720 ↗MalfunctionJul 29, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50070019 ↗MalfunctionJul 28, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50062398 ↗MalfunctionJun 22, 2026Material Separation
THE CUSTOMER RETURNED THE RIGID ENDOSCOPE TELESCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE SERVICE REPORT TECHNICIAN INDICATES THAT CHIPPED LENS WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25585775 ↗MalfunctionJun 16, 2026Break
THE CUSTOMER RETURNED THE RIGID ENDOSCOPE TELESCOPE, WHICH IS AN OLYMPUS ASSET FOR A SEPARATE ISSUE. DURING THE EVALUATION OF THE DEVICE, BROKEN COVER GLASS WAS OBSERVED. THE SERVICE REPAIR TECHNICIAN INDICATED THAT THE MOST LIKELY CAUSE OF THE FINDING WAS DUE TO COMPONENT FAILURE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25525656 ↗MalfunctionJun 6, 2026Detachment of Device or Device Component
THE CUSTOMER RETURNED THE RIGID ENDOSCOPE TELESCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE SERVICE REPAIR TECHNICIAN INDICATES THAT CHIPPED LENS IN OPTICAL SYSTEM WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25418818 ↗MalfunctionMay 31, 2026Crack
THE CUSTOMER REPORTED SHATTERED DURING INSPECTION FOR USE. INVOLVING AN OLYMPUS RIGID ENDOSCOPE TELESCOPE. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25344107 ↗MalfunctionMay 25, 2026Material Fragmentation
IT WAS REPORTED THAT THE RIGID ENDOSCOPE TELESCOPE TIP COMPLETELY BROKEN OFF. THE ISSUE WAS FOUND DURING A SURGICAL PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25272225 ↗MalfunctionMay 20, 2026Break
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID ENDOSCOPE TELESCOPE EXHIBITED A CHIPPED LENS IN THE OPTICAL SYSTEM. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25237549 ↗MalfunctionMay 18, 2026Detachment of Device or Device Component
IT WAS REPORTED THE RIGID ENDOSCOPE TELESCOPE HAD A CHIP IN THE LENS. THIS ISSUE OCCURRED DURING CYSTOSCOPY WITH A BOTOX INJECTION THERAPEUTIC PROCEDURE AND WAS COMPLETED WITH AN OLYMPUS BACK-UP DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25203317 ↗MalfunctionMay 8, 2026Break
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID ENDOSCOPE TELESCOPE HAD CHIPPED LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25127080 ↗MalfunctionMay 5, 2026Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID ENDOSCOPE TELESCOPE EXHIBITED CHIPPED LENS IN OPTICAL SYSTEM. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25085033 ↗MalfunctionMay 5, 2026Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID ENDOSCOPE (TELESCOPE) HAD A CHIPPED LENS IN THE OPTICAL SYSTEM. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25080374 ↗MalfunctionMay 3, 2026Break
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID ENDOSCOPE TELESCOPE EXHIBITED CHIPPED OPTICAL LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25064264 ↗MalfunctionMay 3, 2026Crack
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID ENDOSCOPE TELESCOPE HAD CRACKED OBJECTIVE COVER GLASS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25062817 ↗MalfunctionApr 30, 2026Break
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID ENDOSCOPE TELESCOPE EXHIBITED CHIPPED LENS IN OPTICAL SYSTEM. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25047723 ↗MalfunctionApr 30, 2026Break
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID ENDOSCOPE TELESCOPE HAD CHIPPED LENSES IN OPTICAL SYSTEM. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25039057 ↗MalfunctionApr 24, 2026Material Fragmentation
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID ENDOSCOPE TELESCOPE PRESENTED CHIPPED LENS IN THE OPTICAL SYSTEM. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24988754 ↗MalfunctionApr 22, 2026Break
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID ENDOSCOPE TELESCOPE EXHIBITED CHIPPED LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24953020 ↗MalfunctionApr 22, 2026Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID ENDOSCOPE TELESCOPE EXHIBITED CHIPPED LENS IN OPTICAL SYSTEM. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24950966 ↗MalfunctionApr 20, 2026Break
IT WAS REPORTED THAT RIGID ENDOSCOPE TELESCOPE HAD OCULAR PART BROKEN OFF. THE ISSUE WAS FOUND DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24928133 ↗MalfunctionApr 17, 2026Material Deformation
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID ENDOSCOPE TELESCOPE EXHIBITED CHIPPED AND TOUCH COVER GLASS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24913048 ↗MalfunctionApr 15, 2026Material Fragmentation
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID ENDOSCOPE TELESCOPE HAD CHIPPED OPTICAL LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24883319 ↗MalfunctionApr 13, 2026Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID ENDOSCOPE TELESCOPE EXHIBITED CHIPPED LENS IN OPTICAL SYSTEM. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24858028 ↗MalfunctionApr 9, 2026Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID ENDOSCOPE TELESCOPE EXHIBITED LENS CHIPPED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24837756 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.