BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOSTAT II ELECTROSURGICAL UNIT

    MDR report key: 1202227 · Received October 16, 2008

    Report

    Report Number
    3005099803-2008-05302
    Event Type
    Malfunction
    Date Received
    October 16, 2008
    Date of Event
    September 15, 2008
    Report Date
    September 17, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNS
    PMA / PMN Number
    K913881
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE MANUFACTURE DATE IS UNK. THE DEVICE HAS NOT BEEN RETURNED. THE DEVICE EVALUATION HAS NOT BEEN PERFORMED; THE CAUSE OF THE REPORTED MALFUNCTION IS UNDETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION IN 2008, THAT AN ENDOSTAT II ELECTROSURGICAL UNIT WAS USED TWO DAYS PRIOR. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN PRESSING THE FOOT PEDAL, THE ENDOSTAT II HAD NO OUTPUT POWER EVEN THOUGH AN ABLATION TONE COULD BE HEARD. THE PROCEDURE WAS COMPLETED WITH ANOTHER ENDOSTAT II ELECTROSURGICAL UNIT. 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 II ELECTROSURGICAL UNIT KNS BOSTON SCIENTIFIC CORPORATION M0054080R0 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK