Olympus A22041ARecalls & reported problems
OLYMPUS Winter & Ibe GmbH · Resection sheath, 24 Fr. · Class 2
Data updated Oct 16, 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.
Quick summary
This Olympus resection sheath appears in 659 adverse event reports, with no deaths and 81 injuries. Reports mostly describe the sheath breaking or cracking, sometimes leaving fragments, and some mention a foreign body in the patient. It has 1 open recall, started in November 2025, over complaints that the ceramic tip of the sheath breaks.
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
- 656
- Deaths reported
- 0
- Injuries reported
- 81
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 656 adverse event reports that list this exact device (DI 04042761020961), received between May 4, 2018 and Sep 30, 2026 — classified as 81 injuries, 575 malfunctions.
The most frequently reported specific device problem is “Break” (508 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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-1441-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Break508
- Detachment of Device or Device Component89
- Material Fragmentation85
- Fracture74
- Mechanical Problem73
- Crack30
- Material Separation9
- Loose or Intermittent Connection7
Patient problems
- No Clinical Signs, Symptoms or Conditions564
- No Known Impact Or Consequence To Patient37
- Foreign Body In Patient26
- Insufficient Information9
- No Consequences Or Impact To Patient9
- Device Embedded In Tissue or Plaque4
- Urethral Stenosis/Stricture4
- Hemorrhage/Blood Loss/Bleeding2
Recent adverse event reports
The 25 most recent of 656 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954570 ↗MalfunctionSep 30, 2026Break
The customer returned the resection sheath for a separate issue. During the initial evaluation of the returned device, the ceramic tip was slightly broken. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50941734 ↗MalfunctionSep 23, 2026Material Fragmentation
The customer returned the Resection sheath to the service center for repair replacement noted to have a fault tip cracked. During inspection of the device, the ceramic insulation was found to be chipped, broken off.There was no patient involvement in this reported event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50871799 ↗MalfunctionSep 21, 2026Break
It was reported the Endoscope sheath exhibited a damaged ceramic tip. The issue occurred during inspection for use. There were no reports of patient harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50840132 ↗MalfunctionSep 10, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50722507 ↗MalfunctionAug 27, 2026Break
The customer returned the reusable endoscope sheath, which is an Olympus asset with no reported complaint. During the evaluation of the device, a broken isolation beak was found. There was no patient involvement.
Patient problems: Insufficient Information
MAUDE report 50465675 ↗MalfunctionAug 18, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50311133 ↗MalfunctionAug 17, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50286754 ↗MalfunctionAug 12, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50225561 ↗MalfunctionAug 11, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50214254 ↗MalfunctionAug 7, 2026Break
It was reported that the reusable Endoscope sheath, gray tip is broken. There were no reports of patient harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50184074 ↗MalfunctionAug 7, 2026Break
It was reported that the reusable Endoscope sheath distal end (white part) is broken. The issue occurred out of the Box Failure (e.g. upon receipt or unpacking). There were no reports of patient harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50183815 ↗MalfunctionAug 3, 2026Break; Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50123127 ↗MalfunctionAug 3, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50123069 ↗MalfunctionAug 3, 2026Material Fragmentation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50108419 ↗MalfunctionJul 31, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50105350 ↗MalfunctionJul 29, 2026Material Disintegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50069747 ↗MalfunctionJul 27, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50038132 ↗MalfunctionJul 10, 2026Crack
THE CUSTOMER RETURNED THE ENDOSCOPE SHEATH TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE SERVICE REPAIR TECHNICIAN INDICATED THAT A CRACKED BEAK WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25785029 ↗MalfunctionJul 7, 2026Break
THE CUSTOMER RETURNED THE ENDOSCOPE SHEATH TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE REGIONAL SERVICE CENTER FOUND A BROKEN BEAK. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25728791 ↗MalfunctionJun 25, 2026Break
THE CUSTOMER RETURNED THE REUSABLE ENDOSCOPE SHEATH, TO THE SERVICE CENTER FOR EVALUATION RELATED TO A SEPARATE ISSUE. DURING TESTING, THE FIELD SERVICE ENGINEER IDENTIFIED THE DEVICE CERAMIC TIP WAS BROKEN OR DAMAGED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25628158 ↗MalfunctionJun 25, 2026Break
THE CUSTOMER RETURNED THE ENDOSCOPE SHEATH TO THE SERVICE CENTER FOR EVALUATION RELATED TO A SEPARATE ISSUE. HOWEVER, MDR REPORTABLE FAILURE WAS FOUND DURING TESTING AT THE SERVICE CENTER. DURING INSPECTION IT WAS FOUND THAT THE ISOLATION BEAK (INSULATION BEAK) WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25621443 ↗MalfunctionJun 24, 2026Material Fragmentation
THE CUSTOMER RETURNED THE RESECTION SHEATH TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, BROKEN CERAMIC TIP WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25612261 ↗MalfunctionJun 23, 2026Break
IT WAS REPORTED THAT THE REUSABLE ENDOSCOPE SHEATH, DISTAL END BEAK IS BROKEN. THE ISSUE OCCURRED DURING REPROCESSING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25589502 ↗MalfunctionJun 19, 2026Detachment of Device or Device Component
THE CUSTOMER RETURNED THE REUSABLE ENDOSCOPE SHEATH, TO THE SERVICE CENTER FOR EVALUATION RELATED TO A SEPARATE ISSUE. DURING TESTING, THE SERVICE REPAIR TECHNICIAN IDENTIFIED THE DEVICE BEAK WAS CRACKED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25566942 ↗
Other Resectoscope devices
- Olympus A22040AOLYMPUS Winter & Ibe GmbH · Resectoscope1 recall1,764 reports
- Olympus A42011AOLYMPUS Winter & Ibe GmbH · Resectoscope1 recall963 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
- Olympus A22043AOLYMPUS Winter & Ibe GmbH · Resectoscope1 recall3 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 · each recall links to the FDA recall notice
- 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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