BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARYLAND BIPOLAR FORCEPS INSTRUMENT

    MDR report key: 1022638 · Received March 31, 2008

    Report

    Report Number
    2955842-2008-00161
    Event Type
    Malfunction
    Date Received
    March 31, 2008
    Report Date
    March 31, 2008
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING OBSERVED THE TOP PLUG RISER PIN IS PUSHED INTO THE BACK END OF THE INSTRUMENT AND THE CHASSIS FEATURE THAT RETAINS THE PINS IS BROKEN. IT WAS DETERMINED THAT THE DAMAGE WAS MOST LIKELY DUE TO MISHANDLING. ENGINEERING ALSO OBSERVED THE DISTAL END OF THE MAIN TUBE HAS A 3" LONG SECTION WITH LIGHT MATERIAL REMOVED. THE DAMAGED AREA IS PARALLEL TO MAIN TUBE AXIS. BASED ON THE LOCATION AND APPEARANCE, THE DAMAGE MAY HAVE BEEN CAUSED BY A CANNULA ACCESSORY. NO OTHER DAMAGE WAS 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 MARYLAND BIPOLAR FORCEPS INSTRUMENT WAS BROKEN, AND NO PIECES FELL INSIDE OF THE PATIENT. 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 GEI INTUITIVE SURGICAL, INC. 420172-06 1912061 251

    Patients

    Seq Age Sex Outcome Treatment
    1 DA VINCI S SURGICAL SYSTEMS| ELECTROSURGICAL UNIT.