BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARYLAND BIPOLAR FORCEPS INSTRUMENT

    MDR report key: 1022781 · Received March 28, 2008

    Report

    Report Number
    2955842-2008-00166
    Event Type
    Malfunction
    Date Received
    March 28, 2008
    Date of Event
    February 13, 2008
    Report Date
    March 28, 2008
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING CONFIRMED THE INSTRUMENT MOVED INTUITIVELY WITH FULL RANGE OF MOTION IN ALL DIRECTIONS. THE GRIPS OPENED AND CLOSED PROPERLY AND INSTRUMENT RECOGNITION AND ENGAGEMENT PASSED. ENGINEERING ALSO OBSERVED THE DISTAL END OF THE MAIN TUBE HAS 2 INCH LONG SECTION WITH MATERIAL REMOVED. THE DAMAGED AREA IS 3.5 INCHES ABOVE THE PROXIMAL CLEVIS AND IS PARALLEL TO THE MAIN TUBE AXIS. THE WEAR PATTERN IS CONSISTENT WITH CANNULA RELATED TUBE ABRASIONS. NO OTHER DAMAGE WAS FOUND. ADD'L INVESTIGATION IS UNDERWAY REGARDING THE CANNULA ACCESSORIES. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADD'L INFO IS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI S PROSTATECTOMY SURGICAL PROCEDURE, THE MARYLAND BIPOLAR FORCEPS INSTRUMENT BROKE. NO ADD'L INFO WAS PROVIDED. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MARYLAND BIPOLAR FORCEPS INSTRUMENT ELECTROSURGICAL INSTRUMENT GEI INTUITIVE SURGICAL, INC. 420172-06 0610071 463

    Patients

    Seq Age Sex Outcome Treatment
    1 ACCESSORIES| ELECTROSURGICAL UNIT| DA VINCI S SURGICAL SYSTEM