BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVE CORD

    MDR report key: 1883525 · Received October 26, 2010

    Report

    Report Number
    3005099803-2010-04550
    Event Type
    Malfunction
    Date Received
    October 26, 2010
    Report Date
    October 5, 2010
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KNS
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    *NOTE: THIS REPORT PERTAINS TO ONE OF TWO COMPLAINT DEVICES. MANUFACTURER REPORT # 3005099803-2010-04551 PERTAINS TO THE FIRST ACTIVE CORD. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO ACTIVE CORDS WERE BEING PREPPED FOR USE IN A COLONOSCOPY PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, THE RED CONNECTOR AT THE END OF THE CORD WAS LOOSE AND BROKE OFF. THIS ISSUE HAPPENED AGAIN WITH THE SECOND ACTIVE CORD. A THIRD ACTIVE CORD WAS SUCCESSFULLY USED TO COMPLETE THE PROCEDURE. 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 GOOD.

    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