BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOLAR MARYLAND TIP FORCEPS INSTRUMENT

    MDR report key: 735362 · Received June 23, 2005

    Report

    Report Number
    2955842-2005-00063
    Event Type
    Malfunction
    Date Received
    June 23, 2005
    Date of Event
    May 26, 2005
    Report Date
    May 26, 2005
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING FOUND THAT THE INSTRUMENT GRIP WAS BENT AT THE YAW PULLEY, WHICH PREVENTED THE TIPS FROM MEETING. THE INSTRUMENT WAS RETURNED INTACT, WITH NO PIECES MISSING. ENGINEERING ALSO DISCOVERED SIGNS OF ARC TRACKING, WHICH SPANS FROM GRIP TO GRIP AT THE INSTRUMENT YAW PULLEY. THIS COMPLAINT IS BEING REPORTED DUE TO EVIDENCE OF ARC TRACKING FOUND. THE ARC TRACKING HAS LED ENGINEERING TO CONCLUDE THAT THE INSTRUMENT MAY HAVE ARCED DURING PREVIOUS SURGICAL PROCEDURE.

    Description of Event or Problem · 1

    PRIOR TO BEGINNING THE SURGICAL PROCEDURE, THE CUSTOMER NOTICED THAT THE BIPOLAR MARYLAND TIP FORCEPS INSTRUMENT HAD A BROKEN TIP. NO PT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIPOLAR MARYLAND TIP FORCEPS INSTRUMENT ELECTROSURGICAL INSTRUMENT GEI INTUITIVE SURGICAL, INC. 400172-04 1703051 17

    Patients

    Seq Age Sex Outcome Treatment
    1 *