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Olympus A22042TRecalls & reported problems

OLYMPUS Winter & Ibe GmbH · Resection sheath, 26 Fr., with deflecting obturator · Class 2

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04042761020992), received between Sep 17, 2020 and Aug 18, 2023 — classified as 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.

Recalls naming this device

  1. Nov 11, 2025Open, Classified

    Complaints of the ceramic tip of the resection sheath breaking have been received.

    Z-1444-2026 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Device problems

  • Break2
  • Fracture1
  • Material Fragmentation1

Patient problems

  • Device Embedded In Tissue or Plaque1
  • Foreign Body In Patient1
  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionAug 18, 2023Break; Break

    THE CUSTOMER REPORTED THAT THE TIP OF THE SHEATH WAS CHIPPED. THE ISSUE WAS NOTICED UPON INITIAL REVIEW OF UNPACKAGING. THERE WERE NO REPORTS OF HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17577501 ↗
  • MalfunctionSep 17, 2020Break; Fracture; Material Fragmentation; Break; Fracture; Material Fragmentation

    OLYMPUS WAS INFORMED THAT DURING A THERAPEUTIC TRANSURETHRAL RESECTION OF A BLADDER TUMOR (TURBT) PROCEDURE ON (B)(6) 2020, THE CERAMIC INSULATION AT THE DISTAL END OF THE RESECTION SHEATH BROKE OFF INSIDE THE PATIENT. HOWEVER, THIS WENT UNNOTICED UNTIL (B)(6) 2020, WHEN A CYSTOSCOPY PROCEDURE WAS PERFORMED DUE TO THE RECURRENCE OF THE BLADDER TUMOR, AND A FRAGMENT OF THE BEAK WAS NOTICED INSIDE THE PATIENT'S PROSTATE. DUE TO THE RECURRENCE OF THE BLADDER TUMOR, A FOLLOW-UP TURBT PROCEDURE IS SCHEDULED FOR (B)(6) 2020, DURING WHICH THE BROKEN-OFF FRAGMENT IS TO BE RETRIEVED. THERE WAS NO REPORT ABOUT AN ADVERSE EVENT OR PATIENT INJURY.

    Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient

    MAUDE report 10545202 ↗

Other Resectoscope devices

All Resectoscope devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.