BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPOLAR CURVED SCISSORS INSTRUMENT

    MDR report key: 1133425 · Received August 22, 2008

    Report

    Report Number
    2955842-2008-01239
    Event Type
    Malfunction
    Date Received
    August 22, 2008
    Report Date
    August 22, 2008
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING OBSERVED THAT THE TUBE EXTENSION IS DISLODGED FROM THE INSTRUMENT MAIN TUBE, WITH THE THIN WALLED SECTION OF THE TUBE EXTENSION BROKEN CIRCUMFERENTIALLY AT THE INTERFACE. NO PIECES ARE MISSING. ENGINEERING ALSO OBSERVED CHARRING ON THE TUBE EXTENSION PIECES, INDICATING THAT AN ARCING EVENT OCCURRED. ENGINEERING ALSO DISCOVERED A CHARRED .120" X .060" OBLONG SECTION ON THE DISTAL END OF THE MAIN TUBE, LOCATED .5" ABOVE THE TUBE EXTENSION. THE CHARRING INDICATES THAT A SECOND ARCING EVENT OCCURRED. THE INSTRUMENT WAS DISASSEMBLED AND A SMALL CHAR WAS NOTICED ON THE TUBE EXTENSION SEAL. ENGINEERING ALSO FOUND A CRACK IN THE TUBE THAT STARTS AT ONE SLOT AND ENDS AT THE CHARRED SECTION. IT WAS CONCLUDED THAT THE TUBE EXTENSION BREAKAGE MAY HAVE PROPAGATED THE TUBE CRACK AT THE SLOT WHICH LIKELY CREATED A PATH FOR ARCING TO OCCUR AND HIGH GENERATOR SETTINGS MAY HAVE ALSO CONTRIBUTED TO THE DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER A DA VINCI S TOTAL HYSTERECTOMY SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS INSTRUMENT SNAPPED, HOWEVER, NOTHING FELL INTO THE PATIENT. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MONOPOLAR CURVED SCISSORS INSTRUMENT ELECTROSURGICAL INSTRUMENT GEI INTUITIVE SURGICAL, INC. 420179-08 0804281 237

    Patients

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