BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST PROGRASP INSTRUMENT

    MDR report key: 1232781 · Received November 14, 2008

    Report

    Report Number
    2955842-2008-01380
    Event Type
    Malfunction
    Date Received
    November 14, 2008
    Report Date
    November 14, 2008
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, 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 THE MAIN TUBE HAS A 5.750 INCH AREA, EXTENDED FROM THE INTERFACE BETWEEN THE PROXIMAL CLEVIS AND THE MAIN TUBE, WHERE MATERIAL HAS BEEN REMOVED FROM DIFFERENT SECTIONS OF THE TUBE. THE DAMAGED AREA IS PARALLEL TO THE AXIS AND HAS A ROUGH SURFACE FINISH. BASED ON THE LOCATION AND APPEARANCE, THE DAMGE WAS MOST LIKELY CAUSED BY A CANNULA ACCESSORY. DEEP SCRATCHES WERE ALSO OBSERVED CONCENTRATED WITHIN 2 INCHES FROM THE PROXIMAL CLEVIS WHICH MAY HAVE BEEN CAUSED BY INSTRUMENT COLLISIONS. ADDITIONAL INVESTIGATION IS UNDERWAY REGARDING THE CANNULA ACCESSORIES. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. NO OTHER DAMAGE FOUND. THE ENDOWRIST INSTRUMENTS INSTRUCTIONS FOR USE (IFU) SPECIFICALLY STATES: GENERAL PRECAUTIONS ANS 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 DAMGE 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 ENDOWRIST PROGRASP INSTRUMENT IS SPLINTERING ON THE SHAFT. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOWRIST PROGRASP INSTRUMENT ENDOSCOPIC INSTRUMENT GCJ INTUITIVE SURGICAL, INC. 420093-07 0712071 345

    Patients

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