Olympus A22002ARecalls & reported problems
OLYMPUS Winter & Ibe GmbH · Telescope, 30°, 4 mm · Class 2
Quick summary
This Olympus rigid endoscope telescope is a scope used in hysteroscopy. Most of its 297 reports describe breaks, detached parts or cracks, with chipped lenses and sharp edges noted. The reports mention no deaths and 2 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
- 297
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 297 adverse event reports that list this exact device (DI 04042761020855), received between Jun 16, 2020 and Jul 21, 2026 — classified as 2 injuries, 295 malfunctions.
The most frequently reported specific device problem is “Break” (173 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
Most reported problems
Device problems
- Break173
- Detachment of Device or Device Component49
- Crack27
- Poor Quality Image10
- Component Missing9
- Defective Component5
- Mechanical Problem5
- No Display/Image5
Patient problems
- No Clinical Signs, Symptoms or Conditions292
- No Patient Involvement3
- Insufficient Information1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 25 most recent of 297 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 25889527 ↗MalfunctionMay 23, 2026Sharp Edges
THE CUSTOMER RETURNED THE RIGID ENDOSCOPE TELESCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE SERVICE TEAM INDICATES THAT A SHARP EDGES AT DISTAL END WAS FOUND. IT WAS DETERMINED THAT THE DISTAL END NEEDED TO BE REPLACED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25264826 ↗MalfunctionApr 15, 2026Break
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID ENDOSCOPE TELESCOPE HAD BROKEN OBJECTIVE UNIT LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24882023 ↗MalfunctionMar 23, 2026Material Separation
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID ENDOSCOPE TELESCOPE EXHIBITED CHIP IN OPTICAL SYSTEM. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24663130 ↗MalfunctionMar 19, 2026Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID ENDOSCOPE TELESCOPE EXHIBITED CHIPPED MENISCUS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24637478 ↗MalfunctionMar 9, 2026Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID ENDOSCOPE TELESCOPE'S LENS WAS CHIPPED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24552974 ↗MalfunctionFeb 27, 2026Material Fragmentation
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE RIGID ENDOSCOPE TELESCOPE EXHIBITED CHIPPED LENS. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24474791 ↗MalfunctionFeb 26, 2026Loose or Intermittent Connection
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID ENDOSCOPE TELESCOPE EXHIBITED LOOSE MODEL RING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24454994 ↗MalfunctionFeb 24, 2026Break
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID ENDOSCOPE TELESCOPE HAD AN EYEPIECE WINDOW THAT POPPED OUT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24428171 ↗MalfunctionFeb 19, 2026Break
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID ENDOSCOPE TELESCOPE HAD BROKEN COVER GLASS AT OBJECTIVE WINDOW. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24389712 ↗MalfunctionFeb 19, 2026Unstable
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID ENDOSCOPE TELESCOPE HAD LOOSE EYE PIECE FUNNEL. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24387211 ↗MalfunctionFeb 19, 2026Unstable
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID ENDOSCOPE TELESCOPE HAD LOOSE OBJECT WINDOW. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24387039 ↗MalfunctionFeb 17, 2026Unstable
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE MENISCUS OF RIGID ENDOSCOPE TELESCOPE WAS OUT OF PLACE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24369630 ↗MalfunctionFeb 12, 2026Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID ENDOSCOPE TELESCOPE EXHIBITED LOOSE MENISCUS AT OBJECTIVE WINDOW. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24328650 ↗MalfunctionFeb 12, 2026Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID ENDOSCOPE TELESCOPE OUTER TUBE WAS MISSING THE DIRECTION PIN. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24324423 ↗MalfunctionFeb 12, 2026Break
IT WAS REPORTED THAT THE RIGID ENDOSCOPE TELESCOPE HAD DAMAGED POSITIONING PIN. THE EVENT WAS FOUND DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24323945 ↗MalfunctionFeb 10, 2026Break
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID ENDOSCOPE TELESCOPE EXHIBITED DAMAGE LIGHT GUIDE POST. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24308539 ↗MalfunctionFeb 6, 2026Crack; Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID ENDOSCOPE TELESCOPE HAD EYEPIECE (E/P) FUNNEL BROKEN OFF, AND CRACKS AROUND EYEPIECE (E/P) WINDOW. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24277569 ↗MalfunctionFeb 3, 2026Break
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID ENDOSCOPE TELESCOPE HAD A DAMAGED CONNECTOR PIN. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24245121 ↗MalfunctionJan 20, 2026Break; Scratched Material
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID VIDEO ENDOSCOPE TELESCOPE EXHIBITED BROKEN CONNECTOR PIN, BROKEN INTERNAL LENS AND SCRATCHED EYEPIECE CUP. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24117607 ↗MalfunctionJan 16, 2026Break
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID ENDOSCOPE TELESCOPE EXHIBITED A BROKEN CONNECTOR PIN. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24095013 ↗MalfunctionJan 16, 2026Break
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID ENDOSCOPE TELESCOPE EXHIBITED BROKEN EYEPIECE CUP.. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24092817 ↗MalfunctionJan 15, 2026Crack
NO ADDITIONAL INFORMATION FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24088556 ↗MalfunctionJan 15, 2026Break
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID ENDOSCOPE TELESCOPE BROKEN FIBER DURING SET UP. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24086939 ↗MalfunctionJan 8, 2026Break
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID ENDOSCOPE TELESCOPE EXHIBITED THE BROKEN LOCKING PIN AND A COMPONENT FAILURE OF THE PIN. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24002291 ↗
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 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.