BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROPOSED TRADEMAN MICROVASIVE POLYPECTOMY SNARES

    MDR report key: 2002808 · Received February 28, 2011

    Report

    Report Number
    3005099803-2011-00619
    Event Type
    Malfunction
    Date Received
    February 28, 2011
    Date of Event
    February 7, 2011
    Report Date
    February 7, 2011
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    FDI
    PMA / PMN Number
    K941750
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6): THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE DEVICE EXPIRATION AND DEVICE MANUFACTURED DATES ARE UNKNOWN. (B)(6): 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.

    Additional Manufacturer Narrative · 1

    A THREE-YEAR SHIP HISTORY PERFORMED FOUND THE THREE MOST PROBABLE LOTS FROM WHICH THE COMPLAINT DEVICE ORIGINATED: (B)(4), ALL OF WHICH CORRESPOND TO UPN (B)(4). (B)(4)

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF FOUR DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT #S 3005099803-2011-00613, 3005099803-2011-00614, AND 3005099803-2011-00618 ADDRESS THE OTHER DEVICES. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOSTAT II ELECTROSURGICAL UNIT, AN ENDOSTAT II FOOT SWITCH, AN ACTIVE CORD, AND A SENSATION POLYPECTOMY SNARE WERE USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, POWER DELIVERY TO THE SNARE COULD NOT BE ACHIEVED. THE FOOT SWITCH AND SNARE WERE REPLACED INDIVIDUALLY IN AN ATTEMPT TO IDENTIFY THE PROBLEMATIC SYSTEM COMPONENT; HOWEVER, THE ACTIVE CORD WAS NOT REPLACED. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. FOLLOWING THE PROCEDURE, THE ACTIVE CORD WAS REPLACED, WHICH WAS REPORTED TO HAVE RESOLVED THE ISSUE WITH POWER DELIVERY, AND THIS ACTIVE CORD HAS BEEN USED SUCCESSFULLY SINCE THIS 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 FINE.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF FOUR DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT #S 3005099803-2011-00613, 3005099803-2011-00614, AND 3005099803-2011-00618 ADDRESS THE OTHER DEVICES. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOSTAT II ELECTROSURGICAL UNIT, AN ENDOSTAT II FOOT SWITCH, AN ACTIVE CORD, AND A SENSATION POLYPECTOMY SNARE WERE USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, POWER DELIVERY TO THE SNARE COULD NOT BE ACHIEVED. THE FOOT SWITCH AND SNARE WERE REPLACED INDIVIDUALLY IN AN ATTEMPT TO IDENTIFY THE PROBLEMATIC SYSTEM COMPONENT; HOWEVER, THE ACTIVE CORD WAS NOT REPLACED. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. FOLLOWING THE PROCEDURE, THE ACTIVE CORD WAS REPLACED, WHICH WAS REPORTED TO HAVE RESOLVED THE ISSUE WITH POWER DELIVERY, AND THIS ACTIVE CORD HAS BEEN USED SUCCESSFULLY SINCE THIS 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 FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROPOSED TRADEMAN MICROVASIVE POLYPECTOMY SNARES SNARE, FLEXIBLE FDI BOSTON SCIENTIFIC - COSTA RICA M00562673

    Patients

    Seq Age Sex Outcome Treatment
    1