Olympus A22004ARecalls & reported problems
OLYMPUS Winter & Ibe GmbH · Telescope, 110°, 4 mm · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04042761020879), received between Aug 2, 2023 and Aug 2, 2023 — classified as 2 injuries.
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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryAug 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A PARALEGAL CALLED TO GET THE INSTRUCTION FOR USE FOR THE OES PRO RESECTOSCOPE AND REPORTED TO OLYMPUS THAT DURING A THERAPEUTIC LEFT URETEROSCOPY AND LEFT STENT PLACEMENT, THERE WAS A SEVERE TEAR IN URETER. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE DONE, HOWEVER, UNSUCCESSFUL.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 17443733 ↗InjuryAug 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A PARALEGAL CALLED TO GET THE INSTRUCTION FOR USE FOR THE OES PRO RESECTOSCOPE AND REPORTED TO OLYMPUS THAT DURING A THERAPEUTIC LEFT URETEROSCOPY AND LEFT STENT PLACEMENT, THERE WAS A SEVERE TEAR IN URETER. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE DONE, HOWEVER, UNSUCCESSFUL.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 17443673 ↗
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 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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