BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5MM LAT SERFAS ENERGY PROBE

    MDR report key: 1407782 · Received June 24, 2009

    Report

    Report Number
    2648666-2009-00120
    Event Type
    Injury
    Date Received
    June 24, 2009
    Date of Event
    May 25, 2009
    Report Date
    May 26, 2009
    Manufacturer
    STRYKER ENDOSCOPY PUERTO RICO
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO WILL BE PROVIDED, ONCE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SYNOVECTOMY SURGERY, THE SURGEON NOTICED THAT THE TIP OF THE PROBE WAS BROKEN AND COULD NOT LOCATE THE BROKEN PIECE IN THE PT. HE WAS USING THE CUT MODE AND COAG MODE ALTERNATELY DUE TO THE PT'S HEMOPHILIC CONDITION. AFTER THE SURGERY, X-RAYS WERE TAKEN AND FOUND THE BROKEN PIECE WAS IN THE PT'S POSTERIOR KNEE. A SECOND SURGERY WAS PERFORMED IN THE ATTEMPT TO RETRIEVE THE BROKEN PIECE. THE ADDITIONAL INCISION WAS ABOUT 6 CM AND ALLEGEDLY, THE PT RECEIVED A BLOOD TRANSFUSION BECAUSE THE BLEEDING WOULD NOT STOP. THE BROKEN PIECE WAS NOT RETRIEVED AND WAS LEFT IN THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3.5MM LAT SERFAS ENERGY PROBE PROBE GEI STRYKER ENDOSCOPY PUERTO RICO 09061AE2

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other