BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIPOLAR GOLD PROBE CABLE ADAPTER

    MDR report key: 1413748 · Received May 18, 2009

    Report

    Report Number
    1530493-2009-00004
    Event Type
    Other
    Date Received
    May 18, 2009
    Date of Event
    January 1, 2008
    Report Date
    May 11, 2009
    Manufacturer
    OLSEN MEDICAL
    Product Code
    KNS
    PMA / PMN Number
    PRE-AMEN
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS IN RESPONSE TO THE REPORT AS SUBMITTED BY BOSTON SCIENTIFIC. THE DEVICE HAD BEEN PREVIOUSLY USED WITH NO REPORTED ERRORS. THE CIRCUIT OF THE DEVICE WAS INTERRUPTED, BUT THE CAUSE WAS NOT DETERMINABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION IN 2008, THAT A BIPOLAR CABLE WAS USED DURING A PROCEDURE. ACCORDING TO THE COMPLAINANT, THE CABLE WAS SHORTING OUT AND THERE WAS NO CURRENT GOING THROUGH THE CABLE ADAPTER. ANOTHER BIPOLAR CABLE WAS USED TO COMPLETE THE PROCEDURE. NO INFO WAS AVAILABLE REGARDING THE PT'S CONDITION DURING OR AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIPOLAR GOLD PROBE CABLE ADAPTER CABLE ADAPTER KNS OLSEN MEDICAL M00561360 008416

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK