BEUDAMED
    FDA Adverse Event Summary report: N

    ENDOWRIST PROGRASP FORCEPS INSTRUMENT

    MDR report key: 1023707 · Received March 28, 2008

    Report

    Report Number
    2955842-2008-00173
    Date Received
    March 28, 2008
    Report Date
    April 4, 2008
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    GCJ
    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 CONFIRMED THE DISTAL END OF MAIN TUBE HAS A 1.5 INCH LONG AREA WITH LIGHT MATERIAL REMOVED. THE DAMAGED AREA IS 2.3 INCHES ABOVE THE PROXIMAL CLEVIS, PARALLEL TO THE TUBE AXIS, AND HAS A ROUGH SURFACE FINISH. THE WEAR PATTERN IS CONSISTENT WITH CANNULA RELATED TUBE ABRASIONS. ADDITIONAL INVESTIGATION IS UNDERWAY REGARDING THE CANNULA ACCESSORIES. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. ENGINEERING ALSO OBSERVED TWO AREAS ON THE TUBE DIRECTLY ABOVE THE PROXIMAL CLEVIS EARS WITH MATERIAL REMOVED DUE TO DEEP SCRATCHES. ENGINEERING DETERMINED THE SCRATCHES ARE LIKELY DUE TO INSTRUMENT COLLISIONS. NO OTHER DAMAGE FOUND. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SHAFT ON THE ENDOWRIST PROGRASP FORCEPS INSTRUMENT IS "ROUGHED UP AND LEAVING FIBER SLIVERS ON THE TECHNICIAN'S THUMB". NO ADDITIONAL INFORMATION WAS PROVIDED. NO PATIENT HARM OR ADVERSE OUTCOME WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOWRIST PROGRASP FORCEPS INSTRUMENT ENDOSCOPIC INSTRUMENT GCJ INTUITIVE SURGICAL, INC. 420093-07 0712071 351

    Patients

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