BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOLMIUM LASER FIBER WITH SMARTSYNC

    MDR report key: 3931202 · Received July 10, 2014

    Report

    Report Number
    3931202
    Event Type
    Malfunction
    Date Received
    July 10, 2014
    Date of Event
    July 8, 2014
    Report Date
    July 10, 2014
    Manufacturer
    COOK MEDICAL INC.
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    LASER FIBER SPLIT. ALL PARTS RETRIEVED. NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405672 HOLMIUM LASER FIBER WITH SMARTSYNC LASER FIBER GEX COOK MEDICAL INC. HLF-S273-H30 U2351257

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR URETEROSCOPEH-30 HOLMIUM LASER SYSTEM