BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVOLUTION DSP 23G, ILM FORCEPS

    MDR report key: 1708083 · Received May 27, 2010

    Report

    Report Number
    3003398873-2010-00005
    Event Type
    Malfunction
    Date Received
    May 27, 2010
    Date of Event
    April 22, 2010
    Report Date
    April 27, 2010
    Manufacturer
    ALCON GRIESHABER AG
    Product Code
    HNR
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADD'L REPORTABLE INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "UNKNOWN) (NO INFORMATION). PRODUCT PROBLEM(S): "BROKEN TIP" (BREAK [TIP]). THE CUSTOMER REPORTED A BROKEN TIP WAS FOUND WHEN FORCEPS WAS INSERTED IN THE EYE THROUGH TROCAR. NO PT IMPACT WAS REPORTED. ADD'L FOLLOW-UP INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REVOLUTION DSP 23G, ILM FORCEPS FORCEPS, OPHTHALMIC HNR ALCON GRIESHABER AG 706.44 F74214

    Patients

    Seq Age Sex Outcome Treatment
    1