BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERMEDIC HOOK SHOT FIBER HIGH POWER WITH CHIP

    MDR report key: 6108891 · Received November 17, 2016

    Report

    Report Number
    6108891
    Event Type
    Malfunction
    Date Received
    November 17, 2016
    Date of Event
    September 15, 2016
    Report Date
    November 4, 2016
    Manufacturer
    INTERMEDIC ARFAN, S.A.
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    TIP OF LASER FIBER FOR DIODE LASER BROKE OFF IN PATIENT'S BLADDER DURING PROCEDURE. SURGEON UNABLE TO RETRIEVE FRAGMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    761437 INTERMEDIC HOOK SHOT FIBER HIGH POWER WITH CHIP POWERED LASER SURGICAL INSTRUMENT GEX INTERMEDIC ARFAN, S.A. 00119/2016

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR