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Olympus WA2T470ARecalls & reported problems

OLYMPUS Winter & Ibe GmbH · Telescope "OES ELITE", 4 mm, 70°, HD, autoclavable · Class 2

Quick summary

This Olympus OES Elite telescope, used with hysteroscopes, has 323 reports, all malfunctions, with no deaths and no injuries. Many describe broken or chipped lenses, parts coming loose or detaching, and unstable connections. No recalls name this device. Reports rose to 172 in the last 12 months from 63 in the 12 months 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
323
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 323 adverse event reports that list this exact device (DI 04042761077576), received between Jun 23, 2020 and Aug 10, 2026 — classified as 323 malfunctions.

The most frequently reported specific device problem is “Break” (119 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: 3 reportsDec 2023: 5 reportsJan 2024: 4 reportsFeb 2024: 7 reportsMar 2024: 3 reportsApr 2024: 4 reportsMay 2024: 4 reportsJun 2024: 1 reportsJul 2024: 1 reportsAug 2024: 7 reportsSep 2024: 1 reportsOct 2024: 5 reportsNov 2024: 7 reportsDec 2024: 4 reportsJan 2025: 4 reportsFeb 2025: 5 reportsMar 2025: 10 reportsApr 2025: 3 reportsMay 2025: 1 reportsJun 2025: 8 reportsJul 2025: 5 reportsAug 2025: 10 reportsSep 2025: 3 reportsOct 2025: 3 reportsNov 2025: 8 reportsDec 2025: 5 reportsJan 2026: 11 reportsFeb 2026: 112 reportsMar 2026: 18 reportsApr 2026: 10 reportsMay 2026: 4 reportsJun 2026: 3 reportsJul 2026: 0 reportsAug 2026: 1 reportsSep 2026: 0 reportsOct 2026: 0 reports202420252026112
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Break119
  • Detachment of Device or Device Component76
  • Loose or Intermittent Connection49
  • Unstable31
  • Crack23
  • Material Fragmentation8
  • Material Separation5
  • Poor Quality Image4

Patient problems

  • No Clinical Signs, Symptoms or Conditions322
  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 25 most recent of 323 reports, in the reporter's own words as published by the FDA.

  • MalfunctionAug 10, 2026Unstable

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50194923 ↗
  • MalfunctionJun 22, 2026Material Separation

    THE CUSTOMER RETURNED THE RIGID ENDOSCOPE TELESCOPE TO THE SERVICE CENTER FOR EVALUATION RELATED TO A SEPARATE ISSUE. DURING TESTING, THE SERVICE REPAIR TECHNICIAN IDENTIFIED THE DEVICE HAD LOOSEN APART MENISCUS. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25579334 ↗
  • MalfunctionJun 18, 2026Detachment of Device or Device Component

    THE CUSTOMER REPORTED CHIPPED LENS DURING REPROCESSING INVOLVING AN OLYMPUS RIGID ENDOSCOPE TELESCOPE. THERE WAS NO PATIENT INJURY REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25548578 ↗
  • MalfunctionJun 17, 2026Break

    THE CUSTOMER REPORTED LENS IS SHATTERED DURING A SERVICE / MAINTENANCE INVOLVING AN OLYMPUS RIGID ENDOSCOPE TELESCOPE. THERE WAS NO PATIENT INJURY REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25538377 ↗
  • MalfunctionMay 18, 2026Material Fragmentation

    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 25211699 ↗
  • MalfunctionMay 13, 2026Detachment of Device or Device Component

    IT WAS OBSERVED THAT DURING 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 25166636 ↗
  • 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 25085064 ↗
  • MalfunctionMay 5, 2026Detachment of Device or Device Component

    IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE OBJECTIVE WINDOW MENISCUS OF RIGID ENDOSCOPE TELESCOPE WAS LOOSEN APART. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25084676 ↗
  • MalfunctionApr 27, 2026Material Separation

    IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID ENDOSCOPE TELESCOPE HAD CHIPPED LENS IN THE OPTICAL SYSTEM. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24997686 ↗
  • MalfunctionApr 22, 2026Detachment of Device or Device Component

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

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24956615 ↗
  • MalfunctionApr 22, 2026Detachment of Device or Device Component

    IT WAS REPORTED THAT RIGID ENDOSCOPE TELESCOPE HAD CHIPPED DISTAL END. THERE WERE NO REPORTS OF PATIENT HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24955786 ↗
  • MalfunctionApr 20, 2026Poor Quality Image; Unintended Movement

    NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24928116 ↗
  • MalfunctionApr 13, 2026Detachment of Device or Device Component

    IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID ENDOSCOPE TELESCOPE EXHIBITED THAT THE OBJECTIVE LENSES WAS CHIPPED. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24865594 ↗
  • MalfunctionApr 9, 2026Unstable

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

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24837589 ↗
  • MalfunctionApr 9, 2026Material Fragmentation

    IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID ENDOSCOPE TELESCOPE HAD A CHIPPED DISTAL END. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24830131 ↗
  • MalfunctionApr 9, 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 24829926 ↗
  • MalfunctionApr 6, 2026Detachment of Device or Device Component

    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 24788800 ↗
  • MalfunctionApr 1, 2026Detachment of Device or Device Component

    IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID ENDOSCOPE TELESCOPE HAD CHIPPED LENS IN OPTICAL SYSTEM. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24752532 ↗
  • MalfunctionMar 30, 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 24729314 ↗
  • MalfunctionMar 30, 2026Material Separation

    IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID ENDOSCOPE TELESCOPE HAD A CHIPPED LENS IN OPTICAL SYSTEM. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24722567 ↗
  • MalfunctionMar 30, 2026Material Fragmentation

    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 24719349 ↗
  • MalfunctionMar 30, 2026Detachment of Device or Device Component

    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 24711648 ↗
  • MalfunctionMar 26, 2026Detachment of Device or Device Component

    IT WAS OBSERVED DURING DEVICE EVALUATION, THAT THE RIGID ENDOSCOPE TELESCOPE EXHIBITED DETACHMENT OF LENSES. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24705988 ↗
  • MalfunctionMar 26, 2026Material Deformation

    IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID ENDOSCOPE TELESCOPE HAD CHIPPED LENS IN OPTICAL SYSTEM. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24697919 ↗
  • MalfunctionMar 26, 2026Detachment of Device or Device Component

    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 24696455 ↗

Other Hysteroscope (And Accessories) devices

All Hysteroscope (And Accessories) devices →

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