BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARYLAND BIPOLAR FORCEPS INSTRUMENT

    MDR report key: 2123203 · Received October 10, 2008

    Report

    Report Number
    2955842-2008-01319
    Event Type
    Malfunction
    Date Received
    October 10, 2008
    Report Date
    October 10, 2008
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    NAY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING FOUND THAT THE TOP PLUG RISER PIN IS PUSHED INTO THE BACK END AND THE BOTTOM PIN IS BENT. THE CHASSIS FEATURE THAT KEEPS THE PINS IN PLACE IS BROKEN, MOST LIKELY DUE TO MISHANDLING. ELECTRICAL CONTINUITY PASSED. ENGINEERING ALSO OBSERVED THE DISTAL END OF THE MAIN TUBE TO HAVE A 2" LONG SECTION WITH MATERIAL REMOVED ON ONE SIDE OF THE TUBE. THE DAMAGED AREA IS PARALLEL TO TUBE AXIS AND HAS A ROUGH SURFACE FINISH. BASED ON THE LOCATION AND APPEARANCE, THE DAMAGE WAS MOST LIKELY CAUSED BY A CANNULA ACCESSORY. NO OTHER DAMAGE FOUND. ADD'L INVESTIGATION IS UNDERWAY REGARDING THE CANNULA ACCESSORIES. A F/U MDR WILL BE SUBMITTED IF ADD'L INFO IS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BIPOLAR PLUG IN ON THE MARYLAND BIPOLAR FORCEPS INSTRUMENT BROKE. 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 0712052 016

    Patients

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