Olympus A42011ARecalls & reported problems
OLYMPUS Winter & Ibe GmbH · Resection sheath, 8 mm, for 8.5 mm/26 Fr. outer sheath, ABS · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Olympus resectoscope sheath is a reusable part used in endoscopic procedures. Most of its 958 reports describe parts breaking, and some describe parts detaching. The reports mention no deaths and 21 injuries. One recall, started in November 2025 and still open, concerns complaints that the ceramic tip 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
- 963
- Deaths reported
- 0
- Injuries reported
- 20
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 963 adverse event reports that list this exact device (DI 04042761023658), received between May 4, 2018 and Sep 24, 2026 — classified as 20 injuries, 943 malfunctions.
The most frequently reported specific device problem is “Break” (706 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-1448-2026 · Root cause: Under Investigation by firm · FDA record ↗
Most reported problems
Device problems
- Break706
- Detachment of Device or Device Component128
- Loose or Intermittent Connection41
- Crack29
- Material Fragmentation26
- Fracture23
- Mechanical Problem22
- Material Integrity Problem16
Patient problems
- No Clinical Signs, Symptoms or Conditions947
- No Known Impact Or Consequence To Patient4
- Blood Loss3
- Hemorrhage/Blood Loss/Bleeding3
- Device Embedded In Tissue or Plaque2
- Insufficient Information2
- Laceration(s)2
- Unspecified Tissue Injury2
Recent adverse event reports
The 25 most recent of 963 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 24, 2026Break; Detachment of Device or Device Component
The customer reported the ceramic head damaged during reprocessing involving an Olympus Endoscope sheath, reusable. There was no patient injury reported. During the device evaluation the investigator indicated the ceramic tip is missing.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50883709 ↗MalfunctionSep 22, 2026Break
It was reported that during set up / inspection for use, the resection sheath ceramic head was damaged. There was no harm or injury reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50849759 ↗MalfunctionSep 21, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50848030 ↗MalfunctionSep 15, 2026Break
It was reported that during set up / inspection for use, the resection sheath ceramic head was damaged. There was no harm or injury reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50766464 ↗MalfunctionSep 15, 2026Crack
The device was returned to the service center. During inspection of the device, the resection sheath ceramic tip had cracks. There was no harm or injury reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50766348 ↗MalfunctionSep 10, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50719992 ↗MalfunctionSep 10, 2026Use of Device Problem
The customer returned the reusable Endoscope sheath for a separate issue. During the device analysis, it was observed that the ceramic tip was broken was found. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50717551 ↗MalfunctionSep 9, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50699224 ↗MalfunctionSep 8, 2026Crack
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50680424 ↗MalfunctionSep 8, 2026Unstable
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50676275 ↗MalfunctionSep 2, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50572021 ↗MalfunctionSep 1, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50551253 ↗MalfunctionSep 1, 2026Detachment of Device or Device Component
The customer returned the reusable Endoscope sheath, for a separate issue. During the initial evaluation of the returned device, loose Ceramic tip was observed. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50535884 ↗MalfunctionSep 1, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50535139 ↗MalfunctionAug 28, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50489926 ↗MalfunctionAug 28, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50488995 ↗MalfunctionAug 27, 2026Break
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 broken. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50477517 ↗MalfunctionAug 27, 2026Break
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 was broken. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50476031 ↗MalfunctionAug 26, 2026Detachment of Device or Device Component
It was reported that the ceramic tip of the inner sheath of the resectoscope fell off on its own into the patient¿s uterine cavity. The issue was found during a hysteroscopic endometrial polypectomy procedure. It was eventually removed using multiple sets of instruments. There were no reports of patient harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50459353 ↗MalfunctionAug 26, 2026Break
The customer returned the reusable endoscope sheath for a separate issue. During the initial evaluation of the returned device, it was observed the ceramic tip was broken. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50457980 ↗MalfunctionAug 24, 2026Crack
No new additional information received from the customer.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50421584 ↗MalfunctionAug 21, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50373084 ↗MalfunctionAug 21, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50371636 ↗MalfunctionAug 17, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50286436 ↗MalfunctionAug 14, 2026Break; Material Fragmentation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50262324 ↗
Other Resectoscope devices
- Olympus A22040AOLYMPUS Winter & Ibe GmbH · Resectoscope1 recall1,764 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.