Olympus A22005ARecalls & reported problems
OLYMPUS Winter & Ibe GmbH · Telescope, 30°, wideangle, 4 mm · Class 2
Quick summary
This Olympus A22005A is a wideangle hysteroscope telescope, a rigid endoscope used inside the uterus. The 32 reports mostly describe the scope breaking or coming apart — light guide fibers snapping, adhesive joints and connector pins detaching, and images turning poor — all found during inspection or evaluation with no patient involved. There are no deaths and no injuries. 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
- 32
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 04042761020886), received between Jan 12, 2023 and Feb 10, 2026 — classified as 32 malfunctions.
The most frequently reported specific device problem is “Break” (21 reports).
1 other recall cover devices cleared under the same FDA submission (K897003); they may or may not involve this specific model.
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
- Break21
- Detachment of Device or Device Component4
- Poor Quality Image4
- Excessive Heating1
- Material Integrity Problem1
- Material Separation1
- Mechanical Problem1
- Melted1
Patient problems
- No Clinical Signs, Symptoms or Conditions32
Recent adverse event reports
The 25 most recent of 32 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 10, 2026Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID ENDOSCOPE TELESCOPE EXHIBITED THAT THE LIGHT GUIDE PART LENS HAD COME OFF. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24306558 ↗MalfunctionFeb 4, 2026Break
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID ENDOSCOPE TELESCOPE EXHIBITED THAT THE ADHESIVE CONNECTION OF THE LIGHT GUIDE POST HAD COME LOOSE; THEREFORE, THE POST WAS DETACHED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24260186 ↗MalfunctionJan 20, 2026Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE CONNECTOR PIN OF THE RIGID ENDOSCOPE TELESCOPE WAS DETACHED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24116236 ↗MalfunctionJan 6, 2026Break
IT WAS REPORTED THAT THE RIGID ENDOSCOPE TELESCOPE HAD A DAMAGED LIGHT GUIDE ADAPTER. 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 23973754 ↗MalfunctionDec 9, 2025Break; Break
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID ENDOSCOPE TELESCOPE EXHIBITED THAT SOME LIGHT GUIDE FIBERS WERE BROKEN. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23760601 ↗MalfunctionDec 2, 2025Poor Quality Image; Poor Quality Image
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION THE RIGID ENDOSCOPE TELESCOPE EXHIBITED ADHESIVE COMING OFF. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23696582 ↗MalfunctionNov 26, 2025Break; Break
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23655877 ↗MalfunctionNov 24, 2025Break; Break
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23633880 ↗MalfunctionOct 24, 2025Break; Break
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID VIDEO SCOPE EXHIBITED NO IMAGE DUE TO OPTICAL SYSTEM LENS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23379295 ↗MalfunctionAug 5, 2025Break; Break
IT WAS REPORTED THAT THE SUBJECT DEVICE WAS DEFECTIVE OR BROKEN. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22715816 ↗MalfunctionApr 24, 2025Poor Quality Image; Poor Quality Image
IT WAS REPORTED THE SCOPE PRESENTED CRYSTALLIZATION IN THE EYEPIECE SECTION, AND DARK IMAGE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21903281 ↗MalfunctionMar 25, 2025Break; Break
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID ENDOSCOPE TELESCOPE EXHIBITED THAT INTERNAL LENS IS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21689528 ↗MalfunctionMar 11, 2025Break; Break
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID SCOPE EXHIBITED BROKEN LENS DISPLACEMENT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21572947 ↗MalfunctionFeb 25, 2025Overheating of Device; Overheating of Device
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21458058 ↗MalfunctionFeb 7, 2025Break; Thermal Decomposition of Device; Optical Problem; Break; Thermal Decomposition of Device; Optical Problem
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID SCOPE EXHIBITED SHADOWS, BROKEN LENS, BURNT TIP, AND COMPONENT FAILURE OF THE LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21333454 ↗MalfunctionJan 15, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE FIXING PIN CAME OFF FROM THE SUBJECT DEVICE DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21158727 ↗MalfunctionSep 27, 2024Break; Break
IT WAS REPORTED, THE TELESCOPE, 30°, WIDEANGLE, 4 MM EXHIBITED A BROKEN CERAMIC TIP. THE ISSUE OCCURRED DURING PREPARATION FOR USE FOR A THERAPEUTIC HYSTEROSCOPY PROCEDURE. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20327572 ↗MalfunctionAug 13, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE DEVICE INSPECTION, THE RIGID ENDOSCOPE TELESCOPE'S DIRECTION PIN WAS LOOSE. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19972583 ↗MalfunctionAug 6, 2024Break; Break
IT WAS REPORTED THE RIGID ENDOSCOPE TELESCOPES INSIDE FIBERS WERE BROKEN. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19919561 ↗MalfunctionJul 11, 2024Break; Break
IT WAS REPORTED, THE TELESCOPE HAD A BROKEN EYEPIECE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19721727 ↗MalfunctionApr 30, 2024Break; Break
IT WAS REPORTED THE HYSTEROSCOPE'S LIGHT POST WAS STUCK INSIDE THE LIGHT LEAD. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19213422 ↗MalfunctionApr 3, 2024Break; Break
IT WAS REPORTED THE TELESCOPE HAD A BROKEN BASE OF THE LENS. THE ISSUE OCCURRED DURING AN UNKNOWN PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19031349 ↗MalfunctionApr 1, 2024Break; Break
IT WAS REPORTED, THAT THE HYSTERORESECTOSCOPE HAD THE BASE OF THE LENS BROKEN. THE ISSUE WAS FOUND DURING THE THERAPEUTIC TRANSURETHRAL RESECTION OF THE PROSTATE PROCEDURE WHICH WAS COMPLETED WITH A SIMILAR DEVICE AND NO DELAY. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19015295 ↗MalfunctionFeb 26, 2024Excessive Heating; Excessive Heating
IT WAS REPORTED, THE RIGID SCOPE WAS BURNED. THE ISSUE OCCURRED DURING THE PREPARATION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18780348 ↗MalfunctionJan 10, 2024Break; Break
THE CUSTOMER REPORTED TO OLYMPUS, THE TELESCOPE, HAD A BROKEN LENS. THE ISSUE WAS FOUND DURING PREPARATION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18484017 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K897003. One submission often covers many models, so check the product and lot details in each record.
- Z-2029-2024 · Apr 18, 2024 · Open, ClassifiedOES 4000 Hysteroscope, Model/Catalog Number: A4674A
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.