BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIRECTIONAL LASER PROBE

    MDR report key: 6556886 · Received May 8, 2017

    Report

    Report Number
    MW5069659
    Event Type
    Injury
    Date Received
    May 8, 2017
    Date of Event
    May 2, 2017
    Report Date
    May 5, 2017
    Manufacturer
    SYNERGETICS USA, INC.
    Product Code
    HQB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    FAULTY LASER PROBE BROKE DURING VITRECTOMY CASE. FRAGMENT OF PROBE WAS RECOVERED FROM PT'S EYE. ADD'L PROBE WAS USED IN CASE WITHOUT COMPLICATION. NO APPARENT HARM TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334410 DIRECTIONAL LASER PROBE LASER HQB SYNERGETICS USA, INC. 55.36.25E M429120

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention