BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENACULUM FORCEPS INSTRUMENT

    MDR report key: 1071663 · Received July 8, 2008

    Report

    Report Number
    2955842-2008-01124
    Event Type
    Malfunction
    Date Received
    July 8, 2008
    Report Date
    July 3, 2008
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING FOUND THE LUER PLATE DISLODGED FROM THE CHASSIS AND PUSHED INTO THE BACK END OF THE INSTRUMENT. THE CHASSIS FEATURE THAT RETAINS THAT LUER PLATE IS UNDAMAGED , HOWEVER , ALL OF THE HOUSING PINS ADJACENT TO THE SNAP TABS ARE BROKEN OFF. ENGINEERING CONCLUDED THAT THE INSTRUMENT WAS LIKELY MISHANDLED, CAUSING THE HOUSING TO COME OFF AND THE LUER PLATE TO DISLODGE. ENGINEERING ALSO FOUND THE DISTAL END OF MAIN TUBE HAS A COUPLE OF DEEP SCRATCHES ON ONE SIDE OF THE TUBE WITH MATERIAL REMOVED. THE SCRATCH MARKS ARE DIRECTLY ABOVE THE PROXIMAL CLEVIS AND ARE NOT ALIGNED WITH THE TUBE AXIS. ENGINEERING CONCLUDED THAT THE SCRATCHES WERE MOST LIKELY CAUSED BY INSTRUMENT COLLISIONS OR ROUGH HANDLING. THE ENDOWRIST INSTRUMENTS INSTRUCTIONS FOR USE (IFU) SPECIFICALLY STATES: GENERAL PRECAUTIONS AND WARNINGS. HANDLE INSTRUMENTS WITH CARE. AVOID MECHANICAL SHOCK OR STRESS THAT CAN CAUSE DAMAGE TO THE INSTRUMENTS. DO NOT USE AN INSTRUMENT TO CLEAN DEBRIS FROM ANOTHER INSTRUMENT INTRAOPERATIVELY. THIS MAY RESULT IN DAMAGE TO THE INSTRUMENTS OR OTHER UNINTENDED CONSEQUENCES, SUCH AS DISCONNECTION OF THE INSTRUMENT TIPS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI S SURGICAL PROCEDURE, A PIECE OF THE BACK OF THE TENACULUM FORCEPS INSTRUMENT BROKE OFF. 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 TENACULUM FORCEPS INSTRUMENT ENDOSCOPIC INSTRUMENT GCJ INTUITIVE SURGICAL, INC. 420207-04 1308071 997

    Patients

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