BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KNIFE

    MDR report key: 3791832 · Received January 22, 2014

    Report

    Report Number
    2523835-2014-00004
    Event Type
    Malfunction
    Date Received
    January 22, 2014
    Date of Event
    December 18, 2013
    Report Date
    December 23, 2013
    Manufacturer
    ALCON PRECISION DEVICE - SINKING SPRING
    Product Code
    HNN
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHARMACIST

    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

    A PHARMACIST REPORTED DURING A CATARACT EXTRACTION WITH INTRAOCULAR LENS IMPLANT PROCEDURE THE "KNIFE HAD NO CUT". THE SURGERY WAS COMPLETED WITH NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53269 KNIFE MANUAL OPHTHALMIC SURGICAL INSTRUMENT HNN ALCON PRECISION DEVICE - SINKING SPRING 8065992745 929897M

    Patients

    Seq Age Sex Outcome Treatment
    1