BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARYLAND BIPOLAR FORCEPS INSTRUMENT

    MDR report key: 1232780 · Received November 14, 2008

    Report

    Report Number
    2955842-2008-01378
    Event Type
    Malfunction
    Date Received
    November 14, 2008
    Report Date
    November 14, 2008
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    NAY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING FOUND THE TOP PLUG RISER PIN IS PUSHED INTO THE BACK END AND THE BOTTOM PIN IS BENT, PREVENTING PROPER INSTALLATION OF A BIPOLAR CORD. THE CHASSIS FEATURE THAT RETAINS THE BIPOLAR INSERT AND PINS IS BROKEN. THE INSTRUMENT WAS MOST LIKELY MISHANDLED, BREAKING THE CHASSIS FEATURE. ENGINEERING ALSO FOUND THAT THE DISTAL END OF THE MAIN TUBE HAS 3 INCH LONG SECTION WITH LIGHT MATERIAL REMOVED ON THE SIDE OF THE TUBE. THE DAMAGED AREA IS PARALLEL TO THE 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. ADDITIONAL INVESTIGATION IS UNDERWAY REGARDING THE CANNULA ACCESSORIES. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CAUTERY ATTACHMENT WILL NOT STAY IN THE MARYLAND BIPOLAR FORCEPS INSTRUMENT. NO ADDITIONAL INFORMATION 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 NAY INTUITIVE SURGICAL, INC. 420172-06 0801241 827

    Patients

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