BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INJECTION GOLD PROBE

    MDR report key: 1821288 · Received August 31, 2010

    Report

    Report Number
    3005099803-2010-03583
    Event Type
    Malfunction
    Date Received
    August 31, 2010
    Date of Event
    August 9, 2010
    Report Date
    August 13, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MIAMI
    Product Code
    KNS
    PMA / PMN Number
    K961349
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE DEVICE EXPIRATION AND MANUFACTURE DATES ARE UNKNOWN. ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE HAS BEEN DISPOSED OF AND IS NOT AVAILABLE FOR RETURN. A DEVICE EVALUATION CANNOT BE PERFORMED. IF ANY ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN INJECTION GOLD PROBE DEVICE WAS GOING TO BE USED DURING A COLONOSCOPY PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING TESTING OF THE INJECTION GOLD PROBE DEVICE IN SALINE, THE PROBE WOULD NOT ACTIVATE, WHEN PRESSING ON THE GENERATOR PEDAL. THE CASE WAS COMPLETED WITH A DIFFERENT DEVICE; IT IS NOT KNOWN WHAT DEVICE WAS USED. AFTER THE PROCEDURE WAS COMPLETED, A DIFFERENT INJECTION GOLD PROBE DEVICE WAS USED TO TEST THE GENERATOR; THE GENERATOR WORKED FINE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. AT THE CONCLUSION OF THE PROCEDURE, THE PATIENT'S CONDITION WAS REPORTED TO BE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INJECTION GOLD PROBE UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC - MIAMI M00560150

    Patients

    Seq Age Sex Outcome Treatment
    1