Olympus A22043ARecalls & reported problems
OLYMPUS Winter & Ibe GmbH · Resection sheath, 28 Fr. · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04042761021005), received between Jun 24, 2021 and Oct 17, 2024 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Break” (2 reports).
1 FDA recall record name this device's identifier, 1 still open.
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
Recalls naming this device
- Nov 11, 2025Open, Classified
Complaints of the ceramic tip of the resection sheath breaking have been received.
Z-1445-2026 · Root cause: Under Investigation by firm · FDA record ↗
Most reported problems
Device problems
- Break2
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Burn(s)1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 17, 2024Break; Break
IT WAS REPORTED THE CERAMIC TIP OF THE RIGID ENDOSCOPE SHEATH WAS BROKEN. IT IS UNKNOWN WHEN THE ISSUE OCCURRED. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20469343 ↗MalfunctionSep 12, 2023Break; Break
THE CUSTOMER REPORTED THAT THE CERAMIC TIPS ON SEVERAL OF HIS OLYMPUS RESECTION SHEATHS WERE BREAKING DURING PROCEDURE PREPARATION. SPECIFIC DETAILS REGARDING THESE EVENTS WERE REQUESTED, BUT NO ANSWERS HAVE BEEN PROVIDED AT THIS TIME. THERE WAS NO PATIENT HARM REPORTED AS A RESULT OF THESE EVENTS. THIS REPORT IS RELATED TO REPORTS WITH PATIENT IDENTIFIERS (B)(6).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17729444 ↗InjuryJun 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
UPDATE: THE CUSTOMER CLARIFIED 02JUL2021 THAT THE CUSTOMER DOES NOT USE AN OLYMPUS GENERATOR OR OLYMPUS GROUNDING PADS. THE BURN EXPERIENCED BY THE PATIENT IS NOT RELATED TO THE USE OF AN OLYMPUS DEVICE.
Patient problems: Burn(s)
MAUDE report 12063800 ↗
Other Resectoscope devices
- Olympus A22040AOLYMPUS Winter & Ibe GmbH · Resectoscope1 recall1,764 reports
- Olympus A42011AOLYMPUS Winter & Ibe GmbH · Resectoscope1 recall963 reports
- Olympus A22041AOLYMPUS Winter & Ibe GmbH · Resectoscope1 recall656 reports
- Olympus A22042AOLYMPUS Winter & Ibe GmbH · Resectoscope1 recall55 reports
- Olmypus WA22017AOLYMPUS Winter & Ibe GmbH · Resectoscope1 recall31 reports
- Olympus A22040TOLYMPUS Winter & Ibe GmbH · Resectoscope1 recall23 reports
- Olympus A22041TOLYMPUS Winter & Ibe GmbH · Resectoscope1 recall12 reports
- Olympus A22014AOLYMPUS Winter & Ibe GmbH · Resectoscope1 recall11 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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