BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENACULUM FORCEPS INSTRUMENT

    MDR report key: 1181971 · Received September 22, 2008

    Report

    Report Number
    2955842-2008-01288
    Event Type
    Malfunction
    Date Received
    September 22, 2008
    Report Date
    September 22, 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

    RESULTS/CONCLUSIONS - THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING CONFIRMED THAT THE DISTAL END OF MAIN TUBE HAS A 1" LONG SECTION WITH LIGHT MATERIAL REMOVED ALL AROUND THE TUBE. THERE IS AN AREA ABOVE THIS SECTION WITH THE APPEARANCE OF LIGHT ABRASIONS, HOWEVER, THE TUBE SURFACE IS SMOOTH TO THE TOUCH. THE DAMAGED AREA IS PARALLEL TO TUBE AXIS AND HAS A ROUGH SURFACE FINISH. BASED ON THE LOCATION AND APPEARANCE, THE DAMAGE WAS MOST LIKELY CAUSED BY A CANNULA ACCESSORY. NO OTHER DAMAGE FOUND. ADDITIONAL INVESTIGATION IS UNDERWAY REGARDING THE CANNULA ACCESSORIES. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TENACULUM FORCEPS INSTRUMENT HAS "FIBERGLASS" COMING OFF AND NOTHING FELL INTO PATIENT. 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 0712171 987

    Patients

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