BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVE CORD

    MDR report key: 4242758 · Received November 11, 2014

    Report

    Report Number
    3005099803-2014-03547
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Report Date
    October 20, 2014
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KNS
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE LOT NUMBER. THEREFORE, THE MANUFACTURE DATE AND EXPIRATION DATE ARE UNKNOWN. REPORTED EVENT OF CORD BROKEN. ALTHOUGH THE SUSPECT DEVICE HAS BEEN RECEIVED, THE EVALUATION HAS NOT BEEN COMPLETED. THEREFORE, THE CAUSE OF THE REPORTED MALFUNCTION HAS NOT BEEN DETERMINED. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MDR WILL BE FILED.

    Additional Manufacturer Narrative · 1

    VISUAL EVALUATION OF THE COMPLAINT DEVICE FOUND THE FEMALE CONNECTOR TO BE DETACHED FROM THE CORD. ADDITIONALLY, THE CORD APPEARS TO HAVE BEEN BENT ADJACENT TO THE EDGE OF THE CONNECTOR PRIOR TO FAILURE. THE COMPLAINT WAS CONFIRMED. THE FEMALE CONNECTOR WAS FOUND TO BE DETACHED WHICH IS CONSISTENT WITH THE COMPLAINT INDICATING THAT THE ACTIVE CORD WAS BROKEN. HOWEVER, THE MOST PROBABLE ROOT CAUSE OF THIS EVENT IS UNDETERMINABLE AS AN EXAMINATION OF THE DEVICE, EVENT DESCRIPTION, AND FOLLOW-UP INFORMATION DID NOT PROVIDE ENOUGH INFORMATION TO DETERMINE A ROOT CAUSE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ACTIVE CORD VALLEY LAB WAS USED DURING A PROCEDURE. ACCORDING TO THE COMPLAINANT, THE ACTIVE CORD BROKE. DESPITE NUMEROUS ATTEMPTS BOSTON SCIENTIFIC HAS BEEN UNABLE OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT. 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 VALLEY LAB WAS USED DURING A PROCEDURE. ACCORDING TO THE COMPLAINANT, THE ACTIVE CORD BROKE. DESPITE NUMEROUS ATTEMPTS BOSTON SCIENTIFIC HAS BEEN UNABLE OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725062 ACTIVE CORD UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC - SPENCER M00561270

    Patients

    Seq Age Sex Outcome Treatment
    1