BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVE CORD

    MDR report key: 2874195 · Received December 14, 2012

    Report

    Report Number
    3005099803-2012-06211
    Event Type
    Malfunction
    Date Received
    December 14, 2012
    Report Date
    November 19, 2012
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KNS
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4):THE ISSUE WAS NOTED OUTSIDE THE PATIENT DURING PREPARATION. ACCORDING TO THE COMPLAINANT, THE ACTIVE CORD "STOPPED WORKING"; IT NO LONGER CONNECTED WELL TO THE GENERATOR AND THE RED CONNECTOR WAS DETACHED. THE PROCEDURE WAS COMPLETED WITH A BACKUP CORD, AND THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE.(B)(4):THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISCARDED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT DID NOT PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE DEVICE MANUFACTURED DATE IS UNKNOWN. (B)(4). THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. SHOULD THE DEVICE BE RETURNED, UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ACTIVE CORD WAS "BROKEN AND THE END [WAS] DAMAGED." IT IS UNKNOWN IF THIS ISSUE OCCURRED DURING A PROCEDURE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ACTIVE CORD WAS "BROKEN AND THE END [WAS] DAMAGED." IT IS UNKNOWN IF THIS ISSUE OCCURRED DURING A PROCEDURE.ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTIVE CORD UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC - SPENCER M00561270

    Patients

    Seq Age Sex Outcome Treatment
    1