BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENACULUM FORCEPS INSTRUMENT

    MDR report key: 1022774 · Received March 28, 2008

    Report

    Report Number
    2955842-2008-00172
    Event Type
    Malfunction
    Date Received
    March 28, 2008
    Report Date
    March 28, 2008
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING FOUND THE DISTAL END OF THE MAIN TUBE (CUSTOMER REFERRED TO AS "SHAFT") HAD MATERIAL REMOVED FROM A COMBINATION OF DEEP SCRATCHES AND SCRAPING. THERE ARE VARIOUS SCRATCH MARKS ALL AROUND THE TUBE THAT ARE RANDOMLY ORIENTED IN RELATION TO THE TUBE AXIS. THESE SCRATCHES WERE LIKELY CAUSED BY INSTRUMENT COLLISIONS. ADDITIONALLY, THERE ARE A FEW LONG, NARROW SECTIONS PARALLEL TO THE TUBE AXIS WITH MATERIAL REMOVED. IT IS POSSIBLE THESE MAY HAVE BEEN CAUSED BY A DEFECTIVE CANNULA. NO OTHER DAMAGE FOUND. ADD'L INVESTIGATION IS UNDERWAY REGARDING THE CANNULA ACCESSORIES. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADD'L INFO IS RECEIVED. 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 THE TENACULUM FORCEPS INSTRUMENT SHAFT WAS SPLINTERING. 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 0710232 373

    Patients

    Seq Age Sex Outcome Treatment
    1