BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGETICS 23 G DIRECTIONAL LASER PROBE

    MDR report key: 2478625 · Received February 26, 2012

    Report

    Report Number
    2478625
    Event Type
    Malfunction
    Date Received
    February 26, 2012
    Date of Event
    January 9, 2012
    Report Date
    February 24, 2012
    Manufacturer
    SYNERGETICS
    Product Code
    HQB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    LASER PROBE WAS NOT RECOGNIZED BY LASER MACHINE. ANOTHER PROBE HAD TO BE OPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNERGETICS 23 G DIRECTIONAL LASER PROBE SYNERGETICS 23 G DIRECTIONAL LASER PROBE HQB SYNERGETICS NA 1060122; 04/2014

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR