BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGMASTER

    MDR report key: 3260026 · Received July 26, 2013

    Report

    Report Number
    MW5031246
    Event Type
    Malfunction
    Date Received
    July 26, 2013
    Date of Event
    July 22, 2013
    Report Date
    July 26, 2013
    Manufacturer
    OLYMPUS OF AMERICA
    Product Code
    FAS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PT UNDERWENT A TRANSURETHRAL PROSTATECTOMY AND DURING THE PROCEDURE THE BIPOLAR ELECTRODE LOOP USED FOR RESECTION BROKE OFF DURING THE CASE. THE LOOP WIRE WAS INTENTIONALLY LEFT IN THE PT. A POST-OP PELVIC CT SCAN SHOWED 2 METAL FRAGMENTS WITHIN THE ANTERIOR PROSTATE. CT SCAN DONE ON (B)(6) 2013. DIAGNOSIS OR REASON FOR USE: PROSTATE RESECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350947 SURGMASTER RESECTION ELECTRODE BIPOLAR LOOP FAS OLYMPUS OF AMERICA 13057P02L001

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR