BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EAVP WING ELECTRODE - DEVICE #1

    MDR report key: 1003728 · Received February 20, 2008

    Report

    Report Number
    1418479-2008-00004
    Event Type
    Malfunction
    Date Received
    February 20, 2008
    Date of Event
    January 24, 2008
    Report Date
    February 20, 2008
    Manufacturer
    RICHARD WOLF MEDICAL INSTRUMENTS
    Product Code
    FAS
    PMA / PMN Number
    K970961
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS RECEIVED IN A CONDITION WHICH MAKES TESTING IMPOSSIBLE; HOWEVER, INFORMATION HAS BEEN REQUESTED FROM USER FACILITY TO COMPLETE OUR INVESTIGATION. THERE IS MORE TIME REQUIRED TO INVESTIGATE. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TURB PROCEDURE, THE METAL LOOP SPLIT. THE SURGEON USED THE FIFTH ONE TO FINISH THE CASE ON THE PATIENT. THERE WAS NO CONSEQUENCE TO PATIENT. THE END-USER COMPLETED A PRODUCT FAILURE REPORT AND INDICATED THAT THE PROBLEM COULD NOT CAUSE HARM TO A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EAVP WING ELECTRODE - DEVICE #1 EVAP WING ELECTRODE FAS RICHARD WOLF MEDICAL INSTRUMENTS 8426.1510 351051 STERILE LOT

    Patients

    Seq Age Sex Outcome Treatment
    1