BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9.23 KRYPTONITE TANO 25 GA ASYMMETRICAL MICRO FORCEPS

    MDR report key: 1227064 · Received November 3, 2008

    Report

    Report Number
    1227064
    Event Type
    Malfunction
    Date Received
    November 3, 2008
    Date of Event
    October 27, 2008
    Report Date
    November 3, 2008
    Manufacturer
    SYNERGETICS, INC.
    Product Code
    HNR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS UNDERGOING A PARS PLANA VITRECTOMY WITH MEMBRANE PEELING AND INTERNAL LIMITING MEMBRANE PEELING FOR A MACULAR HOLE, LEFT EYE. WHILE PEELING THE MEMBRANE, THE SURGEON CLOSED THE HANDLE OF THE FORCEPS. WHEN HE PULLED THE FORCEPS OUT OF THE EYE, ONE OF THE "JAWS" OF THE FORCEPS FELL ONTO THE SCLERA OF THE EYE. THE PIECE REMOVED FROM THE EYE, SURGEON EXAMINED THE INSIDE OF THE EYE FOR DEBRIS, NONE FOUND. PROCEDURE COMPLETED WITHOUT FURTHER INCIDENT. PATIENT TO RECOVERY ROOM IN GOOD CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9.23 KRYPTONITE TANO 25 GA ASYMMETRICAL MICRO FORCEPS FORCEPS, OPHTHALMIC HNR SYNERGETICS, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR