Olympus A22040ARecalls & reported problems
OLYMPUS Winter & Ibe GmbH · Inner sheath, for 26 Fr. outer sheath · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
Reports for this Olympus resectoscope mostly describe parts breaking or detaching during use (1,295 reports of breaks), sometimes leaving fragments in the patient. Of 1,755 reports, 159 describe injuries and none describe deaths. It is named in 1 open recall about the ceramic tip of the sheath breaking. There were 372 reports in the last 12 months and 369 the year before.
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
- 1,764
- Deaths reported
- 0
- Injuries reported
- 160
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1,764 adverse event reports that list this exact device (DI 04042761029339), received between May 4, 2018 and Sep 30, 2026 — classified as 160 injuries, 1,604 malfunctions.
The most frequently reported specific device problem is “Break” (1,299 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-1439-2026 · Root cause: Under Investigation by firm · FDA record ↗
Most reported problems
Device problems
- Break1,299
- Detachment of Device or Device Component245
- Material Fragmentation113
- Fracture111
- Mechanical Problem97
- Crack94
- Loose or Intermittent Connection30
- Material Integrity Problem25
Patient problems
- No Clinical Signs, Symptoms or Conditions1,625
- No Known Impact Or Consequence To Patient45
- Foreign Body In Patient42
- No Consequences Or Impact To Patient28
- Device Embedded In Tissue or Plaque10
- Hemorrhage/Blood Loss/Bleeding4
- Insufficient Information4
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available3
Recent adverse event reports
The 25 most recent of 1,764 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Crack
The customer reported that the Inner sheath had crack in beak. The issue occurred during reprocessing. No patient harm was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952196 ↗MalfunctionSep 30, 2026Break; Detachment of Device or Device Component
It was reported the Inner Sheath beak was observed to be chipped during reprocessing. There were no reports of patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949057 ↗MalfunctionSep 25, 2026Break
The customer reported the reusable Endoscope sheath, had a separate issue. During the initial evaluation of the device, it was observed that the ceramic tip is broken. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50893036 ↗MalfunctionSep 24, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50876524 ↗MalfunctionSep 22, 2026Break
The customer returned the reusable Endoscope sheath for a separate issue. During the device analysis, it was observed that ceramic tip is broken was found. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50855814 ↗MalfunctionSep 14, 2026Degraded
The customer reported the Inner sheath had a separate issue. During the initial evaluation of the device it was observed, beak-missing; repair replaced old generation beak. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50756997 ↗MalfunctionSep 11, 2026Break
It was reported the Inner Sheath beak was broken during inspection for use. There were no reports of patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50735032 ↗MalfunctionSep 10, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50721437 ↗MalfunctionSep 10, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50718517 ↗MalfunctionSep 9, 2026Detachment of Device or Device Component
The customer returned the reusable Endoscope sheath for a separate issue. During initial evaluation of the returned device, it was observed that the isolation beak was damaged. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50698449 ↗MalfunctionSep 8, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50678410 ↗MalfunctionSep 4, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50619247 ↗MalfunctionSep 3, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50588891 ↗MalfunctionSep 3, 2026Detachment of Device or Device Component
No additional information received from customer.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50588296 ↗InjurySep 2, 2026Overheating of Device
Patient problems: Urethral Stenosis/Stricture; Urinary Incontinence
MAUDE report 50574050 ↗MalfunctionSep 2, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50555924 ↗MalfunctionSep 1, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50550433 ↗MalfunctionAug 31, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50532656 ↗MalfunctionAug 31, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50532297 ↗MalfunctionAug 29, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50510207 ↗MalfunctionAug 28, 2026Connection Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50509742 ↗MalfunctionAug 28, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50495898 ↗MalfunctionAug 27, 2026Crack
The customer returned the reusable endoscope sheath to the service center for a separate issue. During the device analysis, the service repair technician indicated that the ceramic tip (insulation beak) was cracked. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50481784 ↗MalfunctionAug 27, 2026Break; Detachment of Device or Device Component
The customer returned the Bronchovideoscope to the service center for a separate issue. During the device analysis, the service repair technician indicated that the ceramic tip (insulation beak) was loose. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50480479 ↗MalfunctionAug 27, 2026Break
The customer reported that the ceramic tip was broken during service/maintenance on an Olympus reusable Endoscope sheath. No patient involvement was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50476105 ↗
Other Resectoscope devices
- 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
- Olympus A22043AOLYMPUS Winter & Ibe GmbH · Resectoscope1 recall3 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.