BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVE CORD

    MDR report key: 1944322 · Received January 3, 2011

    Report

    Report Number
    3005099803-2010-05370
    Event Type
    Malfunction
    Date Received
    January 3, 2011
    Date of Event
    December 16, 2010
    Report Date
    December 16, 2010
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KNS
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE DEVICE MANUFACTURE DATE IS UNKNOWN. THE COMPLAINANT INDICATED THAT THE DEVICE 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.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF FOUR DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT #S 3005099803-2010-05369, 3005099803-2010-05371, AND 3005099803-2010-05372 ADDRESS THE OTHER DEVICES. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOSTAT FOOT SWITCH, TWO CAPTIFLEX POLYPECTOMY SNARES, AND AN ACTIVE CORD WERE USED DURING A POLYPECTOMY PROCEDURE PERFORMED ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE NO ENERGY COULD BE DELIVERED TO THE FIRST CAPTIFLEX POLYPECTOMY SNARE. THIS DEVICE WAS SWITCHED OUT FOR ANOTHER CAPTIFLEX POLYPECTOMY SNARE, BUT THE SAME ISSUE OCCURRED. SINCE THE TARGET POLYP WAS REPORTED TO BE VERY SMALL, THE ACCOUNT CHOSE TO USE THE SECOND SNARE TO REMOVE THE POLYP WITHOUT CAUTERY; NO BLEEDING OCCURRED AS A RESULT. THE GENERATOR IN USE WAS AN ENDOSTAT II ELECTROSURGICAL UNIT. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL ENDOSTAT II ELECTROSURGICAL UNIT, THE ORIGINAL ACTIVE CORD, THE ORIGINAL FOOT SWITCH, AND THE SECOND CAPTIFLEX POLYPECTOMY SNARE. NO MALFUNCTION WAS ALLEGED AGAINST THE ENDOSTAT II ELECTROSURGICAL UNIT, AND THIS GENERATOR WAS REPORTED TO HAVE BEEN USED SUCCESSFULLY IN PROCEDURES SINCE THIS EVENT. AFTER THE PROCEDURE, IT WAS NOTED THAT THE OUTER LAYER OF THE FOOT SWITCH CORD WAS TORN WHERE IT CONNECTS TO THE PEDAL. 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 ACTIVE CORD UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC - SPENCER M00561270

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR