BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIRECTIONAL LASER PROBE

    MDR report key: 4088618 · Received September 12, 2014

    Report

    Report Number
    4088618
    Event Type
    Malfunction
    Date Received
    September 12, 2014
    Date of Event
    August 27, 2014
    Report Date
    September 12, 2014
    Manufacturer
    SYNERGETICS, INC.
    Product Code
    HQB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT IS A (B)(6) GENTLEMAN WITH A HISTORY OF PROLIFERATIVE DIABETIC RETINOPATHY, TREATED WITH PANRETINAL PHOTOCOAGULATION, AND A RECENT VITREOUS HEMORRHAGE WITH SUBHYALOID HEMORRHAGE IN THE RIGHT EYE. HE ALSO HAS A HISTORY OF MACULAR EDEMA IN THE RIGHT EYE. HE PRESENTED FOR REMOVAL OF VITREOUS HEMORRHAGE AND LASER TREATMENT IN THE RIGHT EYE. DURING THE LASER APPLICATION, THE LASER PROBE MALFUNCTIONED. IT WAS NOT ABLE TO RETRACT FROM THE CURVED POSITION, MAKING IT DIFFICULT TO REMOVE THE PROBE THROUGH THE STRAIGHT 23 GAUGE CANNULA AND SUPERIOR NASAL SCLEROTOMY. DURING THE ATTEMPT TO REMOVE THE PROBE, IT TOUCHED THE POSTERIOR CAPSULE OF THE LENS, CREATING A HOLE IN THE POSTERIOR CAPSULE. THE 23 GAUGE CANNULA WAS DISLODGED FROM THE SCLEROTOMY AT THE TIME OF REMOVAL. THE PATIENT IS AT INCREASED RISK FOR EARLY CATARACT FORMATION AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    566054 DIRECTIONAL LASER PROBE PHOTOCOAGULATOR AND ACCESSORIES,DIRECTIONAL LASER PROBE HQB SYNERGETICS, INC. * M209540

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR