BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGETICS

    MDR report key: 617229 · Received June 10, 2005

    Report

    Report Number
    617229
    Event Type
    Malfunction
    Date Received
    June 10, 2005
    Date of Event
    June 7, 2005
    Report Date
    June 10, 2005
    Manufacturer
    SYNERGETICS, INC.
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A PATIENT WAS UNDERGOING A TRANS PARS PLANA VITRECTOMY, RETINAL MEMBRANE PEEL, SCLERAL BUCKLE, ENDOLASER, CRYOTHERAPY, FLUID-AIR EXCHANGE, INJECTION OF 12% C3F8 GAS; FOR DENSE VITREOUS HEMORRHAGE, LEFT EYE. AN ENDOLASER WAS PLACED USING POWERS OF 300 TO 500 MW IN THE DURATION OF 0.3 SECONDS. AFTER A FEW SPOTS OF LASER WERE PLACED IN THE MID AND SOFT PERIPHERAL RETINA, PHYSICIAN SAW A CLEAR OBJECT FALL FROM THE ENDOPROBE INTO THE PATIENT'S EYE. THE ENDOLASER WAS STOPPED, THE OBJECT WAS RETRIVED FROM THE RETINAL SURFACE WITH A INTRAOCULAR FORCEP. OVER 900 SPOTS OF LASER WERE PLACED IN THE RETINA. THE EYE WAS THEN INFUSED WITH FILTERED 12% C3F8 GAS. THE SCLEROTOMY SITES WERE CLOSED WITH A 7-0 VICYL SUTURES. THE CONJUNCTIVA WAS CLOSED WITH 6-0 PLAIN GUT SUTURE. ANCEF 100 MG AND 2 MG OF DECADRON WERE INJECTED SUBCONJUNCTIVALLY. ATROPINE 1% EYE DROP AND ERYTHROMYCIN OPTHALMIC OINTMENT WERE PLACED IN THE EYE. AN EYE PATCH AND SHIELD WERE THEN PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNERGETICS ENDO LASER PROBE GEX SYNERGETICS, INC. * 4110127

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR