BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OLYMPUS

    MDR report key: 1980050 · Received February 1, 2011

    Report

    Report Number
    MW5019241
    Event Type
    Injury
    Date Received
    February 1, 2011
    Date of Event
    December 29, 2010
    Report Date
    February 1, 2011
    Manufacturer
    OLYMPUS AMERICA
    Product Code
    FED
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OK, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A CYSTO TURP WAS PERFORMED AND A PIECE OF THE RESECTION SHEATH BROKE OFF INSIDE THE BLADDER. THE PRODUCT USED WAS AN OLYMPUS RESECTION SHEATH (B)(4) WHICH HAS A PLASTIC TIP AND WAS SHEARED OFF INSIDE THE BLADDER. THE BROKEN PIECE WAS ABLE TO BE REMOVED THROUGH CYSTOSCOPY INSTEAD OF A LAPAROTOMY. OLYMPUS REQUESTED THIS SURGERY DEPT TO FILL OUT A QUESTIONAIRE BUT OUR RISK MGMT THOUGHT IT SHOULD BE REPORTED TO FDA. THIS IS THE SECOND TIME THIS TYPE OF INCIDENT HAS OCCURRED WITH THIS PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS RESECTION SHEATH A22040T FED OLYMPUS AMERICA A22040T C2011-SJ-000075

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Disability