BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INJECTION GOLD PROBE

    MDR report key: 1221564 · Received November 5, 2008

    Report

    Report Number
    3005099803-2008-06020
    Event Type
    Malfunction
    Date Received
    November 5, 2008
    Date of Event
    October 3, 2008
    Report Date
    October 8, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNS
    PMA / PMN Number
    K961349
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE COMPLAINANT HAS INDICATED THAT THE SUSPECT DEVICE IS BEING RETURNED FOR EVALUATION, IT HAS NOT BEEN RECEIVED. THE DEVICE EVALUATION HAS NOT BEEN PERFORMED; THE CAUSE OF THE REPORTED MALFUNCTION IS UNDETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION IN 2008 THAT AN INJECTION GOLD PROBE WAS USED DURING AN ESOPHAGOGASTRODUODENOSCOPY PROCEDURE PERFORMED FIVE DAYS PRIOR. ACCORDING TO THE COMPLAINANT, THERE WAS NO OUTPUT (HEAT OR ENERGY) FROM THE PROBE DURING THE PROCEDURE. REPORTEDLY, THE POWER GENERATOR SETTINGS AND CONNECTIONS WERE CHECKED, BUT THE DEVICE STILL DID NOT FUNCTION. THE PROCEDURE WAS COMPLETED WITH ANOTHER INJECTION GOLD PROBE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INJECTION GOLD PROBE KNS BOSTON SCIENTIFIC CORPORATION M00560160 11838081

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK