BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARYLAND BIPOLAR FORCEPS INSTRUMENT

    MDR report key: 1041289 · Received May 9, 2008

    Report

    Report Number
    2955842-2008-00265
    Event Type
    Malfunction
    Date Received
    May 9, 2008
    Report Date
    May 9, 2008
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    NAY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING FOUND NO CABLES OR WIRES BROKEN OR DAMAGED AT THE WRIST. ONE GRIP IS BENT, CREATING A .040" OFFSET AT THE TIPS. YAW PULLEY DOES NOT HAVE SEPARATION AT GLUE JOINT, HOWEVER, THE MOST LIKELY CAUSE OF BENDING IS OVERLOADING THE TIP. ENGINEERING ALSO OBSERVED THE DISTAL END OF MAIN TUBE HAS A 2.0" LONG SECTION WITH MATERIAL REMOVED ON ONE SIDE OF THE TUBE. DAMAGED AREA IS LOCATED DIRECTLY ABOVE THE PROXIMAL CLEVIS, PARALLEL TO TUBE AXIS, AND HAS A ROUGH SURFACE FINISH. BASED ON THE LOCATION AND APPEARANCE, THE DAMAGE MAY HAVE BEEN CAUSED BY A CANNULA ACCESSORY. 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, A BROKEN CABLE WAS FOUND ON A MARYLAND BIPOLAR FORCEPS INSTRUMENT. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED. NO ADD'L INFO WAS PROVIDED. NO PT 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 NAY INTUITIVE SURGICAL, INC. 420172-06 0706071 703

    Patients

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