BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOSTAT ELECTROSURGICAL UNIT

    MDR report key: 1971372 · Received January 27, 2011

    Report

    Report Number
    3005099803-2011-00121
    Event Type
    Malfunction
    Date Received
    January 27, 2011
    Report Date
    January 6, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    KNS
    PMA / PMN Number
    K913881
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - THE REPORTED EVENT OF INTERMITTENT OUTPUT. 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.

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THE UNIT TO BE IN GOOD PHYSICAL CONDITION. AN ELECTRICAL EVALUATION WAS PERFORMED TO VERIFY THE INTEGRITY OF THE OUTPUT CONNECTORS AND INTERNAL CONNECTIONS; NO ISSUES AROSE DURING THIS TESTING. THE COVER WAS THEN REMOVED, AND ALL COMPONENTS INVOLVED IN THE GENERATION, FILTERING, AND DELIVERY OF POWER WERE MANIPULATED WHILE THE OUTPUT WAS MONITORED; NO INTERMITTENT OUTPUT ISSUE WAS OBSERVED. FINALLY, THE RF BOARDS WERE REMOVED AND INSPECTED FOR INADEQUATE SOLDER JOINTS, PRINTED CIRCUIT BOARD (PCB) DAMAGE, AND BROKEN OR DAMAGED PARTS, AND THE FOOT SWITCH WAS INSPECTED FOR BROKEN WIRES; NO VISIBLE ISSUES WERE NOTED. FOLLOWING THIS EVALUATION, THE UNIT PASSED ALL FINAL TESTING. THE CONDITION OF THE RETURNED INCIDENT DEVICE SHOWED NO EVIDENCE OF EITHER THE ALLEGED ISSUE OR ANY DEFECT WHICH COULD HAVE CONTRIBUTED TO THE EVENT. THE COMPLAINT WAS NOT CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO OTHER COMPLAINTS EXIST FOR THE SPECIFIED SERIAL NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOSTAT III ELECTROSURGICAL UNIT WAS USED DURING A PROCEDURE (PROCEDURE DATE UNKNOWN). ACCORDING TO THE COMPLAINANT, THE OUTPUT FROM THE UNIT WAS INTERMITTENT; THUS THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. FOLLOWING THE PROCEDURE, THE BIOMED TESTED THE UNIT AND CONFIRMED INTERMITTENT OUTPUT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOSTAT III ELECTROSURGICAL UNIT WAS USED DURING A PROCEDURE (PROCEDURE DATE UNKNOWN). ACCORDING TO THE COMPLAINANT, THE OUTPUT FROM THE UNIT WAS INTERMITTENT; THUS THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. FOLLOWING THE PROCEDURE, THE BIOMED TESTED THE UNIT AND CONFIRMED INTERMITTENT OUTPUT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    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 M00540200

    Patients

    Seq Age Sex Outcome Treatment
    1