BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANO

    MDR report key: 976048 · Received December 13, 2007

    Report

    Report Number
    976048
    Event Type
    Malfunction
    Date Received
    December 13, 2007
    Date of Event
    October 19, 2007
    Report Date
    November 25, 2007
    Manufacturer
    SYNERGETICS, INC
    Product Code
    HNR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    TIP OF ZACKS TANO FORCEPS BROKE OFF IN EYE. TIP RETRIEVED FROM EYE. INSTRUMENT AND BROKEN PIECE IMMEDIATELY REMOVED FROM ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TANO FORCEPS, SURGICAL, OPHTHALMIC HNR SYNERGETICS, INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR