BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROVASIVE GOLD PROBE

    MDR report key: 2020007 · Received March 16, 2011

    Report

    Report Number
    3005099803-2011-00797
    Event Type
    Malfunction
    Date Received
    March 16, 2011
    Date of Event
    February 23, 2011
    Report Date
    February 23, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MIAMI
    Product Code
    KNS
    PMA / PMN Number
    K970278
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE UPN, 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

    NOTE: THIS REPORT PERTAINS TO ONE OF THREE DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT #S 3005099803-2011-00793 AND 3005099803-2011-00795 ADDRESS THE OTHER DEVICES. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOSTAT II ELECTROSURGICAL UNIT, AN ENDOSTAT FOOT SWITCH, AND A GOLD PROBE WERE USED DURING A GASTROSCOPY PROCEDURE PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, THE GOLD PROBE WAS BEING USED TO RESOLVE A BLEED IN THE PATIENT'S STOMACH WHEN CAUTERY FAILED. AS A MALFUNCTION OF THE GENERATOR WAS SUSPECTED, EFFORTS TO CAUTERIZE WERE ABANDONED AND EPINEPHRINE WAS INJECTED (METHOD UNKNOWN) TO RESOLVE THE BLEED SUCCESSFULLY. 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 MICROVASIVE GOLD PROBE UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC - MIAMI UNK163

    Patients

    Seq Age Sex Outcome Treatment
    1