Olympus A22042ARecalls & reported problems
OLYMPUS Winter & Ibe GmbH · Resection sheath, 26 Fr. · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Olympus A22042A resection sheath is used with a resectoscope for prostate tissue removal. Most of the 55 reports describe the ceramic or plastic tip breaking, cracking, or detaching, sometimes leaving a piece in the patient's bladder that had to be retrieved. There are 14 injuries and no deaths. One open recall, started in November 2025, covers complaints about the ceramic tip breaking.
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
- 55
- Deaths reported
- 0
- Injuries reported
- 14
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 55 adverse event reports that list this exact device (DI 04042761020985), received between Oct 4, 2018 and Aug 27, 2026 — classified as 14 injuries, 41 malfunctions.
The most frequently reported specific device problem is “Break” (42 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-1443-2026 · Root cause: Under Investigation by firm · FDA record ↗
Most reported problems
Device problems
- Break42
- Detachment of Device or Device Component13
- Material Fragmentation4
- Crack3
- Device Fell2
- Component Missing1
- Defective Component1
- Fracture1
Patient problems
- No Clinical Signs, Symptoms or Conditions51
- Foreign Body In Patient4
Recent adverse event reports
The 25 most recent of 55 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 27, 2026Break; Material Fragmentation; Detachment of Device or Device Component
The customer returned the Resection Sheath for a separate issue. During the initial evaluation of the returned device, the ceramic insulation broke off partially at the tip. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50482473 ↗MalfunctionJul 28, 2026Crack
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50061634 ↗MalfunctionJun 22, 2026Break
THE CUSTOMER REPORTED TIP IS BROKEN DURING AN UNSPECIFIED PROCEDURE INVOLVING AN OLYMPUS ENDOSCOPE SHEATH. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25575729 ↗MalfunctionMay 20, 2026Break
IT WAS REPORTED THAT THE SURGEON WAS USING THE RESECTOSCOPE AND THE TIP FELL OFF INTO THE PATIENT'S BLADDER AND WAS RETRIEVED. THE ISSUE OCCURRED DURING A THERAPEUTIC TRANSURETHRAL RESECTION OF THE PROSTATE PROCEDURE UNDER SEDATION. THE PROCEDURE WAS COMPLETED WITH A LITTLE TO NO PROCEDURAL PROLONGATION. THERE WAS NO PATIENT HARM IN RELATION TO THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25229495 ↗MalfunctionFeb 9, 2026Break
NO NEW ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24301066 ↗MalfunctionJan 16, 2026Break; Crack
NO ADDITIONAL INFORMATION RECEIVED FORM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24104779 ↗MalfunctionDec 1, 2025Crack; Detachment of Device or Device Component; Crack; Detachment of Device or Device Component
IT WAS REPORTED THAT THE RESECTION SHEATH, INNER SHEATH AT THE VERY END WHERE THERE IS PLASTIC CRACKED AND BROKEN OFF. THE ISSUE OCCURRED DURING SET-UP. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23689357 ↗MalfunctionNov 26, 2025Break; Break
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23660209 ↗MalfunctionAug 26, 2025Break; Break
IT WAS REPORTED THE RESECTION SHEATH CERAMIC TIP WAS DAMAGED DURING PREPARATION FOR AN UNSPECIFIED PROCEDURE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22899043 ↗MalfunctionJul 31, 2025Break; Component Missing; Break; Component Missing
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22672951 ↗MalfunctionJun 25, 2025Break; Break
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RESECTION SHEATH, 26 FR, THE CERAMIC TIP WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22326530 ↗MalfunctionJun 4, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED, THE RESECTION SHEATH, 26 FR. HAD A BLACK PIECE ON THE END THAT NEEDS TO BE GLUED BACK IN. THE EVENT OCCURRED AT REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22141443 ↗MalfunctionMay 27, 2025Defective Component; Defective Component
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22088694 ↗MalfunctionMar 25, 2025Break; Break
THERE IS NO NEW INFORMATION PROVIDED BY THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21686927 ↗MalfunctionMar 24, 2025Break; Break
NO ADDITIONAL INFORMATION WAS PROVIDED BY THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21676069 ↗MalfunctionMar 19, 2025Break; Break
THIS EVENT OCCURRED DURING REPROCESSING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21645297 ↗InjuryMar 11, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
DURING A CYSTOSCOPY WITH CLOT EVACUATION AND FULGURATION OF BLEEDING VESSELS, AN OLYMPUS OBTURATOR WAS BEING USED WHEN THE DISTAL BLACK CERAMIC TIP OF THE 26 FR INNER SHEATH DETACHED AND FELL INTO THE PATIENT¿S BLADDER. THE TIP WAS SUCCESSFULLY RETRIEVED BY THE SURGEON, AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER ISSUES. A 22 FR 3-WAY CATHETER WAS INSERTED AND CONNECTED TO CONTINUOUS BLADDER IRRIGATION. THE INSTRUMENT AND DETACHED TIP WERE QUARANTINED. NO FURTHER HARM TO THE PATIENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21580121 ↗InjuryMar 11, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
DURING A CYSTOSCOPY WITH CLOT EVACUATION AND FULGURATION OF BLEEDING VESSELS, AN OLYMPUS OBTURATOR WAS BEING USED WHEN THE DISTAL BLACK CERAMIC TIP OF THE 26 FR INNER SHEATH DETACHED AND FELL INTO THE PATIENT¿S BLADDER. THE TIP WAS SUCCESSFULLY RETRIEVED BY THE SURGEON, AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER ISSUES. A 22 FR 3-WAY CATHETER WAS INSERTED AND CONNECTED TO CONTINUOUS BLADDER IRRIGATION. THE INSTRUMENT AND DETACHED TIP WERE QUARANTINED. NO FURTHER HARM TO THE PATIENT WAS REPORTED. THE INCIDENT WAS REPORTED VIA MEDWATCH REPORT MW5166406.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21580111 ↗InjuryMar 10, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A CYSTOSCOPY PROCEDURE, THE CERAMIC TIP OF THE SUBJECT DEVICE FELL OFF INTO THE PATIENT¿S BLADDER. THE TIP WAS RETRIEVED, AND THE PROCEDURE WAS COMPLETED. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21567375 ↗InjuryMar 10, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A CYSTOSCOPY PROCEDURE, THE CERAMIC TIP OF THE SUBJECT DEVICE FELL OFF INTO THE PATIENT¿S BLADDER. THE TIP WAS RETRIEVED, AND THE PROCEDURE WAS COMPLETED. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21566768 ↗MalfunctionFeb 21, 2025Break; Break
IT WAS REPORTED THE TIP OF THE RESECTION SHEATH WAS BROKEN OFF. THE ISSUE WAS OBSERVED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21434508 ↗MalfunctionJan 9, 2025Break; Break
IT WAS REPORTED THAT THE SUBJECT DEVICE HAD BROKEN TIP. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21117987 ↗MalfunctionJan 8, 2025Break; Break
IT WAS REPORTED THAT THE TIP WAS BROKEN. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21105324 ↗InjuryJan 2, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE TIP OF THE RESECTION SHEATH SPONTANEOUSLY DETACHED FROM THE SHAFT INSIDE THE PATIENT'S BLADDER DURING A UROLOGIC PROCEDURE UNDER SEDATION. THE COMPONENT HAD TO BE CRUSHED USING A SURGICAL PUNCHER TO RETRIEVE IT, BUT THE ENTIRE COMPONENT HAD COME OFF. THERE WAS NO FURTHER REPORT OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21062261 ↗MalfunctionNov 27, 2024Break; Break
IT WAS REPORTED, THE SUBJECT DEVICE HAD A SMALL PORTION OF THE CERAMIC PIECE BREAK OFF. THE ISSUE WAS FOUND, DURING AN UNSPECIFIED DIAGNOSTIC PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENT HARM WAS REPORTED, BY THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20800887 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.