BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST PROGRASP FORCEPS INSTRUMENT

    MDR report key: 1203504 · Received October 17, 2008

    Report

    Report Number
    2955842-2008-01329
    Event Type
    Malfunction
    Date Received
    October 17, 2008
    Report Date
    October 17, 2008
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING FOUND THE INSTRUMENT TO BE MISSING ONE RELEASE LEVER. THE HOUSING IS INTACT BUT ONE PIN ADJACENT TO A FRONT SNAP TAB IS CRACKED. ENGINEERING CONCLUDED THAT THE HOUSING LIKELY POPPED OFF DURING MISHANDLING, CAUSING THE LEVER TO FALL OUT. THE HOUSING WAS THEN PUT BACK ON WITHOUT THE LEVER. ENGINEERING'S EVALUATION ALSO OBSERVED THE DISTAL END OF THE MAIN TUBE TO HAVE VARIOUS DEEP SCRATCHES WITH MATERIAL REMOVED. SCRATCHES ARE NOT ALIGNED WITH THE TUBE AXIS AND MAY BE DUE TO INSTRUMENT COLLISIONS AND/OR ROUGH HANDLING. 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 CONSEQUENCES, SUCH AS DISCONNECTION OF THE INSTRUMENT TIP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PIECE HAD BROKEN OFF OF THE ENDOWRIST PROGRASP FORCEPS INSTRUMENT. THE BROKEN PIECE DID NOT FALL INTO THE PT. THE BROKEN PIECES WERE DISCARDED AT THE CUSTOMER SITE. NO PT HARM, ADVERSE OUTCOME OR INJURY 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 1310071 783

    Patients

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