BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SNAP-FIT

    MDR report key: 3190310 · Received June 18, 2013

    Report

    Report Number
    3190310
    Event Type
    Malfunction
    Date Received
    June 18, 2013
    Date of Event
    June 13, 2013
    Report Date
    June 18, 2013
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    NAY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US

    Narratives

    Description of Event or Problem · 1

    SNAPFIT SCALPEL WHICH ATTACHES TO THE INSTRUMENT CAME OFF OF INSTRUMENT WHEN SURGEON WAS ROBOTICALLY BIFURCATING THE UTERUS. ABDOMEN WAS SEARCHED ROBOTICALLY AND THE SCALPEL WAS RECOVERED AND NOTED TO BE BENT BUT INTACT. PER SURGEON, MAY HAVE BEEN BENT FROM STRESS AND LONG USE WITH A VERY LARGE FIBROID IN UTERUS.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?PATIENT WITH HISTORY OF FIBOIDS AND ENDOMETRIOSIS. UNDERWENT ROBOTIC LAPAROSCOPIC HYSTERECTOMY REMOVED WITH MORCELLATION, BILATERAL SALPINGECTOMY, AND APPENDECTOMY. PATIENT HAD A 16-WEEK SIZE MULTILOBULAR FIBROID UTERUS WITH SAPROPHYTIC CONNECTIONS OF HER UTERUS AND FIBROIDS TO THE BOWEL.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277297 SNAP-FIT SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT NAY INTUITIVE SURGICAL, INC. * MAZZ690 AND M10121105

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR