BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOSTAT FOOTSWITCH

    MDR report key: 2153299 · Received August 21, 2008

    Report

    Report Number
    3005099803-2008-02082
    Event Type
    Malfunction
    Date Received
    August 21, 2008
    Date of Event
    April 21, 2008
    Report Date
    April 22, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNS
    PMA / PMN Number
    K913881
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER IS UNK; THEREFORE, THE MANUFACTURE DATE CANNOT BE DETERMINED. THE DEVICE HAS NOT BEEN RETURNED. A DEVICE ANALYSIS CANNOT BE PERFORMED; THEREFORE, THE CAUSE OF THE REPORTED EVENT IS UNDETERMINED. THE (B)(6) 2008 15-MONTH HEMOSTASIS GENERATOR AND ACCESSORIES PRODUCT FAMILY COMPLAINT TREND REPORT, INCLUSIVE OF ALL FAILURE MODES, WAS REVIEWED; NO UNFAVORABLE TREND WAS NOTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORP ON (B)(6) 2008 THAT AN ENDOSTAT FOOTSWITCH WAS CONNECTED TO A GENERATOR. ACCORDING TO THE COMPLAINANT, WHEN THE ACCESSORY FOOT SWITCH WAS PRESSED, THERE WAS NO POWER. THE FOOT SWITCH CABLE WAS LATER FOUND TO BE BROKEN. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOSTAT FOOTSWITCH KNS BOSTON SCIENTIFIC CORPORATION M00540740 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1