BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALCON GRIESHABER

    MDR report key: 1584219 · Received January 19, 2010

    Report

    Report Number
    MW5014420
    Event Type
    Malfunction
    Date Received
    January 19, 2010
    Date of Event
    January 12, 2010
    Report Date
    January 19, 2010
    Manufacturer
    ALCON LABORATORIES INC.
    Product Code
    HNF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT WITH PROLIFERATIVE DIABETIC RETINOPATHY WITH TRACTION FOVEAL DETACHMENT FROM VITREAL FOVEAL TRACTION LEFT EYE. DURING SURGERY - PARS PLANA VITRECTOMY, INDIRECT PANRETINAL LASER, MEMBRANE PEELING LEFT EYE - THE MPC SCISSORS WERE INTRODUCED INTO THE LEFT EYE. THE SURGEON NOTED A BROKEN TIP ON THE SCISSORS AND THE TIP WAS SEEN TO BE ADJACENT TO THE CUTTER IN THE LEFT EYE. THE SCISSORS WERE REMOVED AND THE BROKEN TIP CAME OUT WITH THE SCISSORS AND WAS RETRIEVED. NO OTHER METAL WAS NOTED IN THE EYE. AN XRAY WAS NEGATIVE FOR METAL. THE SURGERY WAS COMPLETED AND THE PT WAS TAKEN TO THE RECOVERY ROOM IN EXCELLENT CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALCON GRIESHABER MPC SCISSORS HNF ALCON LABORATORIES INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other