Olympus WA20021ARecalls & reported problems
OLYMPUS Winter & Ibe GmbH · Telescope, 4 mm, 12°, long · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Olympus WA20021A hysteroscope telescope is used to look inside the uterus. The 31 reports mostly describe the telescope breaking or cracking, a lens coming loose under the cover glass, a sharp edge at the tip, and occasional poor images; one report describes an injury. No deaths were reported, and no recalls name 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
- 31
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 04042761051422), received between Dec 14, 2022 and May 8, 2026 — classified as 1 injury, 30 malfunctions.
The most frequently reported specific device problem is “Break” (11 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break11
- Crack8
- Loose or Intermittent Connection5
- Detachment of Device or Device Component2
- Poor Quality Image2
- Unstable2
- Connection Problem1
- Material Split, Cut or Torn1
Patient problems
- No Clinical Signs, Symptoms or Conditions31
- Insufficient Information1
Recent adverse event reports
The 25 most recent of 31 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 8, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT THE RIGID ENDOSCOPE TELESCOPE HAD A LENS THAT WAS NOT SEATED PROPERLY. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25130754 ↗MalfunctionApr 22, 2026Material Split, Cut or Torn
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID ENDOSCOPE TELESCOPE HAD A SHARP EDGE AT THE DISTAL END. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24957983 ↗MalfunctionFeb 23, 2026Loose or Intermittent Connection
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE AUTOCLAVABLE TELESCOPES EXHIBITED LOOSE MENISCUS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24417560 ↗MalfunctionFeb 23, 2026Unstable
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE AUTOCLAVABLE TELESCOPES HAD LOOSE MENISCUS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24415965 ↗MalfunctionFeb 20, 2026Unstable
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE AUTOCLAVABLE TELESCOPES HAD LOOSE MENISCUS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24401440 ↗MalfunctionFeb 17, 2026Loose or Intermittent Connection
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE AUTOCLAVABLE TELESCOPE HAD MENISCUS LOOSE UNDER COVER GLASS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24363044 ↗MalfunctionFeb 16, 2026Loose or Intermittent Connection
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE AUTOCLAVABLE TELESCOPE EXHIBITED A LOOSE MENISCUS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24343384 ↗MalfunctionFeb 4, 2026Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID TELESCOPE EXHIBITED LOOSE MENISCUS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24259523 ↗MalfunctionJan 16, 2026Crack
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24092978 ↗MalfunctionJan 9, 2026Break
IT WAS REPORTED THAT THE AUTOCLAVABLE TELESCOPE EXHIBITED BROKEN SCOPE. THE EVENT OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24027000 ↗MalfunctionDec 15, 2025Break; Break
IT WAS REPORTED THAT THE RIGID SCOPE WAS BROKEN, DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23802970 ↗MalfunctionDec 12, 2025Loose or Intermittent Connection; Loose or Intermittent Connection
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23789666 ↗MalfunctionJul 15, 2025Break; Break
IT WAS REPORTED THE SUBJECT DEVICE BROKE. THE ISSUE WAS FOUND DURING A THERAPEUTIC PROSTATE LASER ENUCLEATION WITH MORCELLATION PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22507092 ↗MalfunctionJun 23, 2025Break; Break
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22310395 ↗MalfunctionMar 3, 2025Break; Break
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE EXHIBITED BROKEN OPTIC LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21505073 ↗MalfunctionMar 3, 2025Crack; Crack
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID SCOPE EXHIBITED BROKEN OPTICAL LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21502023 ↗MalfunctionFeb 25, 2025Crack; Crack
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21465426 ↗MalfunctionFeb 19, 2025Break; Break
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID SCOPE EXHIBITED BROKEN LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21413840 ↗MalfunctionFeb 12, 2025Connection Problem; Connection Problem
IT WAS REPORTED THAT THE CONNECTION OF THE SUBJECT DEVICE WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21371121 ↗MalfunctionSep 5, 2024Crack; Crack
IT WAS REPORTED, THE TELESCOPE OPTIC HAD A CRACK. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20152301 ↗MalfunctionAug 14, 2024Crack; Crack
IT WAS REPORTED THAT THE AUTOCLAVABLE TELESCOPE HAD A CRACK INSIDE THE UNIT. THE ISSUE OCCURRED DURING PREPARATION FOR USE FOR A THERAPEUTIC, UNKNOWN PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19988181 ↗MalfunctionJul 26, 2024Loose or Intermittent Connection; Loose or Intermittent Connection
IT WAS REPORTED, THE AUTOCLAVABLE TELESCOPES CONNECTOR WAS LOOSE AND MISSING WHERE IT CONNECTS WITH THE LIGHT CABLE. THE ISSUE OCCURRED, DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM OR INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19840924 ↗InjuryApr 1, 2024Poor Quality Image; Poor Quality Image
IT WAS REPORTED THAT DURING A THERAPEUTIC TRANSURETHRAL RESECTION OF PROSTATE PROCEDURE, THE TELESCOPE ON ITS FIRST USE DID NOT FAIL DURING THE PROCEDURE, BUT IT GAVE A VIEW OF THE UPPER EDGE OF THE SHAFT AND NOT COAGULATION LOOP. THE PATIENT WAS ON GENERAL ANESTHESIA AND PROCEDURE WAS DELAYED (UNSPECIFIED TIME) AND COULD NOT BE COMPLETED. THE PROCEDURE WAS POSTPONED AND LATER CANCELLED TO BE SCHEDULED FOR ANOTHER DAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19014342 ↗MalfunctionMar 13, 2024Break; Break
IT WAS REPORTED, THE TELESCOPE, 4 MM, 12°, LONG EXHIBITED A BROKEN ROD LENS. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18893846 ↗MalfunctionMar 8, 2024Break; Break
IT WAS REPORTED, THE RIGID SCOPE WAS BROKEN. THE ISSUE OCCURRED DURING REPROCESSING. THE INTENDED PROCEDURE WAS COMPLETED. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18867637 ↗
Other Hysteroscope (And Accessories) devices
- Olympus WA2T430AOLYMPUS Winter & Ibe GmbH · Hysteroscope (And Accessories)783 reports
- Olympus WA2T412AOLYMPUS Winter & Ibe GmbH · Hysteroscope (And Accessories)453 reports
- Olympus A22001AOLYMPUS Winter & Ibe GmbH · Hysteroscope (And Accessories)366 reports
- Olympus WA2T470AOLYMPUS Winter & Ibe GmbH · Hysteroscope (And Accessories)323 reports
- Olympus A22002AOLYMPUS Winter & Ibe GmbH · Hysteroscope (And Accessories)297 reports
- Olympus A22003AOLYMPUS Winter & Ibe GmbH · Hysteroscope (And Accessories)198 reports
- n.a. 27040XAKarl Storz GmbH & Co. KG · HYSTEROSCOPE (AND ACCESSORIES)102 reports
- Myosure Reach Tissue Removal Device 10-401FCHologic, Inc. · HYSTEROSCOPE (AND ACCESSORIES)4 deaths99 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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