BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVE CORD

    MDR report key: 1903426 · Received November 19, 2010

    Report

    Report Number
    3005099803-2010-04799
    Event Type
    Injury
    Date Received
    November 19, 2010
    Date of Event
    October 28, 2010
    Report Date
    October 28, 2010
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KNS
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ACTIVE CORD FAILS TO DELIVER CURRENT. ALTHOUGH THE COMPLAINANT HAS INDICATED THAT THE SUSPECT DEVICE IS BEING RETURNED FOR EVALUATION, IT HAS NOT BEEN RECEIVED. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE DEVICE MANUFACTURE DATE IS UNKNOWN. ADDITIONAL INFORMATION: THE COMPLAINANT INDICATED THAT THE SUSPECT DEVICE WAS BROKEN AFTER THE PROCEDURE; THUS IT IS NO LONGER BEING RETURNED.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF FOUR DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT NUMBERS 3005099803-2010-04783, 3005099803-2010-04784, AND 3005099803-2010-04785 ADDRESS THE OTHER DEVICES. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ACTIVE CORD WAS USED DURING A POLYPECTOMY PROCEDURE PERFORMED ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, TWO POLYPS WERE REMOVED FROM THE PATIENT'S COLON WITH NO APPARENT COMPLICATIONS. HOWEVER, THE COMPLAINANT REPORTED THAT THERE WAS NO EVIDENCE OF BLANCHING WHEN CAUTERY WAS ACTIVATED. THE PHYSICIAN BELIEVED THAT THERE MAY HAVE BEEN AN ISSUE WITH THE GENERATOR. SEVERAL HOURS LATER, THE PATIENT WAS ADMITTED TO AN EMERGENCY ROOM DUE TO BLEEDING, AND A HEMOSTASIS PROBE AND SEPARATE GENERATOR WERE USED TO RESOLVE THE BLEED. IT WAS REPORTED THAT NEITHER A TRANSFUSION NOR HEMOSTASIS CLIPS WERE NEEDED. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF FOUR DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT NUMBERS 3005099803-2010-04783, 3005099803-2010-04784, AND 3005099803-2010-04785 ADDRESS THE OTHER DEVICES. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ACTIVE CORD WAS USED DURING A POLYPECTOMY PROCEDURE PERFORMED ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, TWO POLYPS WERE REMOVED FROM THE PATIENT'S COLON WITH NO APPARENT COMPLICATIONS. HOWEVER, THE COMPLAINANT REPORTED THAT THERE WAS NO EVIDENCE OF BLANCHING WHEN CAUTERY WAS ACTIVATED. THE PHYSICIAN BELIEVED THAT THERE MAY HAVE BEEN AN ISSUE WITH THE GENERATOR. SEVERAL HOURS LATER THE PATIENT WAS ADMITTED TO AN EMERGENCY ROOM DUE TO BLEEDING, AND A HEMOSTASIS PROBE AND SEPARATE PROCEDURE SET WERE USED TO RESOLVE THE BLEED. IT WAS REPORTED THAT NEITHER A TRANSFUSION NOR HEMOSTASIS CLIPS WERE NEEDED. THE ORIGINAL ACTIVE CORD WAS USED IN SEVERAL PROCEDURES FOLLOWING THIS PROCEDURE AND WAS REPORTED TO BE WORKING FINE. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE. AN INITIAL MDR WAS SUBMITTED FOR THIS ACTIVE CORD BECAUSE IT WAS UNKNOWN AT THE TIME OF SUBMISSION WHICH SYSTEM COMPONENT(S) CONTRIBUTED TO THE DIFFICULTIES CAUTERIZING. FOLLOW-UP INFORMATION HAS SINCE REVEALED THAT THIS ACTIVE CORD WAS SUCCESSFULLY USED IN SEVERAL PROCEDURES FOLLOWING THE PROCEDURE DESCRIBED ABOVE, AND THE ACCOUNT ALLEGED NO MALFUNCTION OF THE DEVICE.

    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 47 YR Required Intervention