BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOSTAT ELECTROSURGICAL UNIT

    MDR report key: 1903425 · Received November 19, 2010

    Report

    Report Number
    3005099803-2010-04784
    Event Type
    Injury
    Date Received
    November 19, 2010
    Date of Event
    October 28, 2010
    Report Date
    October 28, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    KNS
    PMA / PMN Number
    K913881
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF THIS REPORT IS (B)(6) 2010.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE LOT NUMBER OF THE DEVICE WAS REPORTED TO BE S08377. VISUAL EVALUATION OF THE RETURNED DEVICE FOUND THAT THE FOOT SWITCH WAS IN GOOD CONDITION, AND MECHANICAL EVALUATION FOUND THAT IT FUNCTIONED PROPERLY. THE FOOT SWITCH AND THE ENDOSTAT II ELECTROSURGICAL UNIT PASSED THE RETURN EVALUATION PROCEDURE WITHIN ALL TEST PARAMETERS. ALL CONNECTIONS WERE CHECKED AND WIRES WERE MANIPULATED WHILE POWER WAS ACTIVATED, AND NO PROBLEMS COULD BE FOUND WITH THE SYSTEM. THE COMPLAINT WAS NOT CONFIRMED.

    Additional Manufacturer Narrative · 1

    (B)(4).THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. 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.

    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, 3005099803-2010-04785, AND 3005099803-2010-04799 ADDRESS THE OTHER DEVICES. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOSTAT FOOT SWITCH 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, 3005099803-2010-04785, AND 3005099803-2010-04799 ADDRESS THE OTHER DEVICES. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOSTAT FOOT SWITCH 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, 3005099803-2010-04785, AND 3005099803-2010-04799 ADDRESS THE OTHER DEVICES.IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(4) 2010 THAT AN ENDOSTAT FOOT SWITCH 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOSTAT ELECTROSURGICAL UNIT UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC - MARLBOROUGH M00540740 S08377

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention