BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST PROGRASP FORCEPS

    MDR report key: 3112181 · Received July 27, 2007

    Report

    Report Number
    2955842-2006-00198
    Event Type
    Malfunction
    Date Received
    July 27, 2007
    Date of Event
    January 25, 2006
    Report Date
    July 27, 2007
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN THE COMPLAINT WAS ORIGINALLY REPORTED TO ISI, SCRATCHES AND/OR SCRAPES WERE CONSIDERED BY ISI ENGINEERING AS SIGNS OF NORMAL INSTRUMENT WEAR AND TEAR. THE ISI CLINICAL SALES REP REPORTED THAT HE BELIEVES THE DOCTORS WERE HITTING THE INSTRUMENTS TOGETHER DURING SURGERIES. THE INSTRUMENTS WERE NOT FOUND TO HAVE BEEN USED WITH DAMAGED CANNULAE. SCRATCHES ON THE MAIN TUBE OF THE INSTRUMENT ARE NOW CONSIDERED EVIDENCE THAT FINE PARTICULATE MAY POTENTIALLY HAVE BEEN SCRAPED FROM THE INSTRUMENT. NO CONCLUSION CAN BE MADE REGARDING WHETHER THE SCRATCHES OCCURRED INTRA-OPERATIVELY, DURING NON-SURGICAL HANDLING OR DURING INSTRUMENT STORAGE. NO CONCLUSION CAN BE MADE REGARDING WHETHER ANY PARTICULATE WAS GENERATED INTRA-OPERATIVELY.

    Description of Event or Problem · 1

    A HOSPITAL REPORTED THAT FIVE (5) INSTRUMENTS WERE SHOWING EVIDENCE OF SCRATCHES AND/OR SCRAPES ON THE "HOUSING". NO PT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED. THE FOLLOWING MEDWATCH REPORTS HAVE BEEN SENT TO THE FDA FOR THE FIVE (5) INSTRUMENTS AFFECTED: 2955842-2013-00194, 00195, 00196, 00197.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOWRIST PROGRASP FORCEPS ENDOSCOPIC INSTRUMENT GCJ INTUITIVE SURGICAL, INC. 400093-05 2908051

    Patients

    Seq Age Sex Outcome Treatment
    1