Olympus A22001ARecalls & reported problems
OLYMPUS Winter & Ibe GmbH · Telescope, 12°, 4 mm · Class 2
Quick summary
This Olympus hysteroscope telescope is a rigid scope used with hysteroscopes. Of its 366 reports, 364 are malfunctions and 2 are injuries, with no deaths. Many reports describe parts that break or shatter, lenses that come off, and sharp edges at the tip, and many were found during inspection with no patient involvement. 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
- 366
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 366 adverse event reports that list this exact device (DI 04042761020848), received between Oct 12, 2022 and Jul 21, 2026 — classified as 2 injuries, 364 malfunctions.
The most frequently reported specific device problem is “Break” (191 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
- Break191
- Detachment of Device or Device Component86
- Component Missing16
- Loose or Intermittent Connection16
- Poor Quality Image13
- Crack12
- Mechanical Problem8
- Material Integrity Problem5
Patient problems
- No Clinical Signs, Symptoms or Conditions365
- Hemorrhage/Blood Loss/Bleeding1
- Hyponatremia1
- Uterine Perforation1
Recent adverse event reports
The 25 most recent of 366 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 21, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25889522 ↗MalfunctionMay 28, 2026Break
THE CUSTOMER RETURNED THE GYNECOLOGY HYSTEROSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE SERVICE REPAIR TECHNICIAN IDENTIFIED THAT THE INTERNAL LENS WAS SHATTERED, AND IT WAS DETERMINED THAT THE DAMAGE WAS CAUSED BY A FAILURE OF THE INTERNAL LENS COMPONENT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25323161 ↗MalfunctionMay 23, 2026Sharp Edges
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE HYSTEROSCOPE, GYNECOLOGY HAD SHARP EDGES AT THE DISTAL END. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25264252 ↗MalfunctionMay 23, 2026Break
THE HYSTEROSCOPE, GYNECOLOGY WAS RETURNED TO THE SERVICE CENTER WITH A REPORT OF NO CUSTOMER ALLEGATION. THIS DOES NOT INDICATE AN MDR REPORTABLE EVENT. HOWEVER, MDR REPORTABLE FAILURE WAS FOUND DURING TESTING AT THE SERVICE CENTER. DURING INSPECTION OF THE DEVICE, SHARP EDGES ON THE DISTAL END WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25264171 ↗MalfunctionMay 21, 2026Break
IT WAS REPORTED THAT THE GYNECOLOGY HYSTEROSCOPE HAD A SHATTERED INTERNAL LENS. THE ISSUE WAS IDENTIFIED DURING INSPECTION PRIOR TO USE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25243714 ↗MalfunctionMay 4, 2026Detachment of Device or Device Component
IT WAS REPORTED THE RIGID SCOPE HAD LENS CAME OFF DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25075570 ↗MalfunctionApr 27, 2026Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE HYSTEROSCOPE, GYNECOLOGY EXHIBITED DETACHMENT OF THE OBJECTIVE LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25010534 ↗MalfunctionApr 25, 2026Break
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE OLYMPUS HYSTERORESECTOSCOPE HAD SHATTERED INTERNAL LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24991791 ↗MalfunctionApr 1, 2026Material Split, Cut or Torn
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GYNECOLOGY HYSTEROSCOPE HAD MENISCUS CHIPPED AND TOUCHING COVER GLASS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24754899 ↗MalfunctionMar 30, 2026Loose or Intermittent Connection
IT WAS REPORTED THE HYSTERORESECTOSCOPE EXHIBITED MISALIGNED LENS. THE ISSUE OCCURRED DURING THE MAINTENANCE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24733729 ↗MalfunctionMar 25, 2026Break
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE HYSTEROSCOPE, GYNECOLOGY EXHIBITED CHIPPED LENSES. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24691230 ↗MalfunctionMar 25, 2026Sharp Edges
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GYNECOLOGY HYSTEROSCOPE HAD A SHARP EDGES AND DAMAGED GLASS DISTAL END. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24689333 ↗MalfunctionMar 24, 2026Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE HYSTEROSCOPE, GYNECOLOGY EXHIBITED CHIPPED LENSES. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24672499 ↗MalfunctionMar 23, 2026Break; Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE HYSTEROSCOPE, GYNECOLOGY HAD EXTREMELY WORN DISTAL TERMINAL AND BROKEN DISTAL LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24661243 ↗MalfunctionMar 19, 2026Break
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID SCOPE EXHIBITED DAMAGED DISTAL END. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24643469 ↗MalfunctionMar 17, 2026Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GYNECOLOGY HYSTEROSCOPE EXHIBITED THAT THE DISTAL END LENS WAS SHIFTED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24617220 ↗MalfunctionMar 9, 2026Break
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GYNECOLOGY HYSTEROSCOPE HAD EXHIBITED A BROKEN AND CHIPPED INNER BARREL ASSEMBLY. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24550782 ↗MalfunctionMar 3, 2026Detachment of Device or Device Component
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24503149 ↗MalfunctionMar 2, 2026Detachment of Device or Device Component
IT WAS REPORTED THE HYSTEROSCOPE, GYNECOLOGY HAD THE PIN HAD COMES OFF. THE EVENT HAD OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24487997 ↗MalfunctionFeb 27, 2026Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE HYSTEROSCOPE GYNECOLOGY HAD A LOOSE MENISCUS ON THE OBJECTIVE WINDOW. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24471456 ↗MalfunctionFeb 27, 2026Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE HYSTEROSCOPE GYNECOLOGY HAD A DETACHED ADAPTER. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24468384 ↗MalfunctionFeb 27, 2026Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GYNECOLOGIC HYSTEROSCOPE HAD A DETACHED ADAPTER. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24468304 ↗MalfunctionFeb 24, 2026Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GYNECOLOGY HYSTEROSCOPE EXHIBITED THAT THE ADAPTER WAS DETACHED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24431380 ↗MalfunctionFeb 23, 2026Loose or Intermittent Connection
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GYNECOLOGY HYSTEROSCOPE PRESENTED LOOSE MENISCUS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24411796 ↗MalfunctionFeb 20, 2026Loose or Intermittent Connection
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE HYSTEROSCOPE, GYNECOLOGY HAD LOOSE MODEL RING AND MENISCUS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24399527 ↗
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 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
- VISERA HYSTEROVIDEOSCOPE OLYMPUS HYF TYPE VOlympus Medical Systems Corp. · HYSTEROSCOPE (AND ACCESSORIES)1 recall48 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.