BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FENESTRATED BIPOLAR FORCEPS

    MDR report key: 7178773 · Received January 10, 2018

    Report

    Report Number
    7178773
    Event Type
    Malfunction
    Date Received
    January 10, 2018
    Date of Event
    November 30, 2017
    Report Date
    December 5, 2017
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    NAY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING ROBOT ASSISTED LAPAROSCOPIC INGUINAL HERNIA (LIH) REPAIR-SURGEON WAS USING FENESTRATED BIPOLAR GRASPER TO PULL SUTURE THROUGH TISSUE AND ONE OF TWO "ARMS" ON GRASPER BROKE OFF INSIDE PATIENT. PIECE WAS ABLE TO BE RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21799 FENESTRATED BIPOLAR FORCEPS SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT NAY INTUITIVE SURGICAL, INC. N10170925-

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR