BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITREORETINAL FORCEPS

    MDR report key: 3769640 · Received January 23, 2013

    Report

    Report Number
    1932402-2013-00001
    Event Type
    Malfunction
    Date Received
    January 23, 2013
    Date of Event
    January 2, 2013
    Report Date
    January 18, 2013
    Manufacturer
    SYNERGETICS, INC.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE APPEARS TO BE OVER EIGHT YEARS AND IN NEED OF PROPER MAINTENANCE.

    Description of Event or Problem · 1

    TIP OF INSTRUMENT BROKE OFF IN THE EYE. THE TIP WAS RETRIEVED BY THE SURGEON. THE PLANNED SUTURELESS SURGERY REQUIRED A SUTURE TO CLOSE THE WOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34131 VITREORETINAL FORCEPS MICRO FORCEPS FRN SYNERGETICS, INC. 39.23.25 NOT KNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention