BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROVASIVE GOLD PROBE

    MDR report key: 2001460 · Received February 25, 2011

    Report

    Report Number
    3005099803-2011-00556
    Event Type
    Injury
    Date Received
    February 25, 2011
    Date of Event
    February 4, 2011
    Report Date
    February 4, 2011
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    KNS
    PMA / PMN Number
    K885005
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE DEVICE EXPIRATION AND DEVICE MANUFACTURED DATES ARE 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 THREE DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT #S 3005099803-2011-00555 AND 3005099803-2011-00557 ADDRESS THE OTHER DEVICES. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOSTAT II ELECTROSURGICAL UNIT, A SENSATION POLYPECTOMY SNARE, AND AN ACTIVE CORD WERE USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, THE UNIT WAS IN THE MONOPOLAR "COAG" MODE SET AT 20 WATTS. DURING POWER DELIVERY, THE PATIENT'S LEG BEGAN TO ABRUPTLY THRUST FORWARD; THE ACCOUNT SUSPECTED HE WAS BEING SHOCKED. AN ENTIRELY DIFFERENT PROCEDURE SET WAS USED TO COMPLETE THE PROCEDURE. 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 MICROVASIVE GOLD PROBE UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC - COSTA RICA M00562670

    Patients

    Seq Age Sex Outcome Treatment
    1 Other