BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOSTAT ELECTROSURGICAL UNIT

    MDR report key: 1931386 · Received December 17, 2010

    Report

    Report Number
    3005099803-2010-05278
    Event Type
    Malfunction
    Date Received
    December 17, 2010
    Date of Event
    November 30, 2010
    Report Date
    November 30, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    KNS
    PMA / PMN Number
    K913881
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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

    VISUAL EVALUATION OF THE RETURNED DEVICE FOUND SOME MINOR SCRATCHES ON THE LEFT SIDE OF THE COVER; OTHERWISE THE UNIT APPEARED TO BE IN GOOD PHYSICAL CONDITION. ALL KNOBS AND SWITCHES WORKED PROPERLY DURING A FUNCTIONAL EVALUATION, DURING WHICH IT WAS ALSO FOUND THAT THE PUMP HEAD SCREWS WERE NOT SECURELY FASTENED. THE UNIT PASSED THE ELECTRICAL PORTION OF THE RETURN EVALUATION PROCEDURE, BUT DID NOT PASS THE IRRIGATION FLOW TEST DUE TO A DEFECTIVE MOTOR; THE COMPLAINT WAS CONFIRMED. THE MOTOR'S OUTPUT WOULD FLUCTUATE AND, AFTER SEVERAL MINUTES OF RUNNING, THE MOTOR WOULD NOT PUMP AT ALL. THE REPORTED FAILURE WAS LIKELY DUE TO LONG OR EXTENDED USE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOSTAT II ELECTROSURGICAL UNIT WAS USED DURING A PROCEDURE PERFORMED ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, THE PUMP FAILED TO PUMP WITH SUFFICIENT FLOW AND PRESSURE. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. 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 II ELECTROSURGICAL UNIT WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2010. ACCORDING TO THE COMPLAINANT, THE PUMP FAILED TO PUMP WITH SUFFICIENT FLOW AND PRESSURE. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. 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 M00540800

    Patients

    Seq Age Sex Outcome Treatment
    1