BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRYKER ENDOSCOPY 90 DEGREE CUTTING LOOP ELECTRODE 24 FR, .014 WIRE

    MDR report key: 1047160 · Received May 19, 2008

    Report

    Report Number
    MW5006926
    Event Type
    Injury
    Date Received
    May 19, 2008
    Date of Event
    April 24, 2008
    Report Date
    May 2, 2008
    Product Code
    KNS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING SURGERY ON THIS DATE FOR TURP AND REMOVAL OF BLADDER STONES FOR URINARY RETENTION, IT WAS NOTED THAT THE IGLESIAS' LOOP HAD BROKEN SUCH THAT ONLY THE TWO PRONGS WERE VISIBLE OUTSIDE OF THE SCOPE. A PIECE OF THE LOOP WAS NOTED TO BE ON THE BLADDER FLOOR AND REMOVED INTACT. REVIEW REVEALED THAT NO INJURY OCCURRED TO THE PATIENT FROM THE BROKEN DEVICE. DATES OF USE: 2008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRYKER ENDOSCOPY 90 DEGREE CUTTING LOOP ELECTRODE 24 FR, .014 WIRE LOOP ELECTRODE KNS STRKF02

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention