Olympus WA2T43WARecalls & reported problems
OLYMPUS Winter & Ibe GmbH · Telescope "OES ELITE", 4 mm, 30 °, wide-angle, HD, autoclavable · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Olympus OES Elite telescope is a 4 mm wide-angle scope used in hysteroscopy. The 26 reports describe breakage such as cracked, chipped or detached lenses and cracks or breaks in the shaft, found during inspection or reprocessing with no deaths and no injuries mentioned. 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
- 26
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 04042761077569), received between Jan 3, 2023 and May 11, 2026 — classified as 26 malfunctions.
The most frequently reported specific device problem is “Break” (13 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break13
- Crack4
- Detachment of Device or Device Component3
- Material Integrity Problem2
- Poor Quality Image2
- Component Missing1
- Defective Component1
- Fracture1
Patient problems
- No Clinical Signs, Symptoms or Conditions26
Recent adverse event reports
The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 11, 2026Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID ENDOSCOPE TELESCOPE EXHIBITED DETACHED LENSES. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25135474 ↗MalfunctionMar 25, 2026Break
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 24686763 ↗MalfunctionFeb 26, 2026Break
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24454848 ↗MalfunctionFeb 6, 2026Crack
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID ENDOSCOPE TELESCOPE HAD CRACKS ON THE SURFACE OF THE ROOT OF THE INSERTION SECTION. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24280163 ↗MalfunctionJan 5, 2026Moisture Damage
IT WAS OBSERVED DURING THE DEVICE EVALUATION THAT THE RIGID SCOPE HAD A BURST DRYING RING BENEATH THE EYEPIECE WINDOW. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23967600 ↗MalfunctionDec 30, 2025Crack; Crack
IT WAS REPORTED THAT THE RIGID ENDOSCOPE TELESCOPE HAD A CHIPPED LENS. THE ISSUE HAD OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23924098 ↗MalfunctionSep 12, 2025Fracture; Material Integrity Problem; Fracture; Material Integrity Problem
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID SCOPE EXHIBITED A FRACTURED PIN, THE TUBE BODY WAS FOLDED AND THERE WAS A COMPONENT FAILURE OF THE INSERTION TUBE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23036629 ↗MalfunctionJul 17, 2025Break; Break
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE EXHIBITED BROKEN OBJECTIVE LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22530552 ↗MalfunctionJul 7, 2025Break; Break
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE EXHIBITED THE FOLLOWING ISSUES: DISTAL END WAS BROKEN, LIGHT GUIDE BUNDLE WAS FRACTURED AND LENS DISPLACED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22413961 ↗MalfunctionJun 27, 2025Break; Defective Component; Break; Defective Component
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE EXHIBITED THE SCOPE INSERTION TUBE WAS BROKEN AND COMPONENT FAILURE OF THE INSERTION TUBE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22344895 ↗MalfunctionMay 13, 2025No Display/Image; No Display/Image
THERE WAS NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22009699 ↗MalfunctionMar 24, 2025Break; Break
IT WAS REPORTED THAT THE SUBJECT DEVICE WAS BROKEN. IT WAS UNKNOWN WHEN THE ISSUE OCCURRED. THERE WAS NO REPORT OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21675326 ↗MalfunctionDec 11, 2024Crack; Crack
IT WAS REPORTED THAT THE SUBJECT DEVICE HAD A LENS CRACKED. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20906787 ↗MalfunctionNov 20, 2024Break; Break
IT WAS REPORTED, THE SUBJECT DEVICE EXHIBITED BROKEN LENS WHEN LOOKING THROUGH THE EYEPIECE. THE ISSUE OCCURRED AT REPROCESSING AFTER THE COMPLETION OF AN UNSPECIFIC THERAPEUTIC PROCEDURE WHICH WAS COMPLETED USING THE SAME DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20737806 ↗MalfunctionOct 1, 2024Component Missing; Component Missing
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID ENDOSCOPE TELESCOPE EXHIBITED LIGHT GUIDE (LG) CONNECTOR ON THE MAIN BODY WAS MISSING. THE ISSUE WAS DISCOVERED AFTER THE DIAGNOSTIC HYSTEROSCOPY PRODUCER, WHEN THE NURSE ATTEMPTED TO DISMANTLE THE SCOPE FROM THE LIGHT SOURCE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20345427 ↗MalfunctionMay 6, 2024Break; Break
IT WAS REPORTED, THAT THE RIGID ENDOSCOPE TELESCOPE HAD A BROKEN LENS. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19249250 ↗MalfunctionMar 18, 2024Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT THE RIGID ENDOSCOPE TELESCOPE'S LIGHT GUIDE CONNECTION PORT WAS DAMAGED. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18921071 ↗MalfunctionJan 12, 2024Break; Break
A CUSTOMER REPORTED TO OLYMPUS, DURING REPROCESSING, THE TELESCOPE HAD A CRACKED LENS. THERE WAS NO REPORT OF PATIENT HARM ASSOCIATED WITH THIS EVENT. THE DEVICE WAS RETURNED FOR EVALUATION. DURING THE DEVICE EVALUATION, THE FOLLOWING REPORTABLE MALFUNCTION WAS IDENTIFIED: A BROKEN LENS WITH BLURRY IMAGE. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18507678 ↗MalfunctionDec 18, 2023Break; Break
THE CUSTOMER REPORTED TO OLYMPUS THAT THE TELESCOPE "OES ELITE", 4 MM, 30 °, WIDE-ANGLE, HD, AUTOCLAVABLE HAD A CHIP IN THE TELESCOPE. THE ISSUE WAS FOUND DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18351970 ↗MalfunctionDec 7, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
THE CUSTOMER REPORTED TO OLYMPUS, IMAGE WAS NOT DISPLAYED AND PARTS WERE DAMAGED ON THE OLYMPUS RIGID SCOPE. THE DEVICE WAS RETURNED FOR EVALUATION. DURING THE DEVICE EVALUATION, THE FOLLOWING REPORTABLE MALFUNCTION WAS FOUND: THE LIGHT GUIDE CONNECTION PIN CAME OFF. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING THE DEVICE EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18284202 ↗MalfunctionOct 29, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
THE CUSTOMER REPORTED TO OLYMPUS, THE DIRECTION PIN DETACHED FROM THE TELESCOPE "OES ELITE". THE ISSUE WAS FOUND DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18026839 ↗MalfunctionSep 11, 2023Break; Break
THE CUSTOMER REPORTED THAT THE DISTAL END WAS BROKEN AND THE COLUMNAR GLASS WAS OFFSET. THE ISSUE WAS FOUND DURING REPROCESSING. THERE WERE NO REPORTS OF HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17725275 ↗MalfunctionSep 8, 2023Break; Break
THE CUSTOMER REPORTED THAT THE CERAMIC TIP BROKEN. THERE WERE NO REPORTS OF HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17715433 ↗MalfunctionJan 25, 2023Break; Break
IT WAS FURTHER REPORTED THAT THE ¿SPLIT OPTICS¿ ISSUE WAS FOUND DURING A DIAGNOSTIC UROLOGY PROCEDURE. THE INTENDED PROCEDURE WAS COMPLETED WITHOUT DELAY USING OTHER EQUIPMENT. NO DEVICE FRAGMENT FELL INTO THE PATIENT. NO IMPACT OR COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16244200 ↗MalfunctionJan 17, 2023Poor Quality Image; Poor Quality Image
IT WAS REPORTED TO OLYMPUS THAT A TELESCOPE RESECTOSCOPE HAD A BLURRY IMAGE. THE REPORTABLE EVENT WAS FOUND DURING ESTIMATION OF THE DEVICE. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16189618 ↗
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- Olympus A22001AOLYMPUS Winter & Ibe GmbH · Hysteroscope (And Accessories)366 reports
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- n.a. 27040XAKarl Storz GmbH & Co. KG · HYSTEROSCOPE (AND ACCESSORIES)102 reports
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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