BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KNIFE

    MDR report key: 3791833 · Received January 22, 2014

    Report

    Report Number
    2523835-2014-00003
    Event Type
    Malfunction
    Date Received
    January 22, 2014
    Date of Event
    December 16, 2013
    Report Date
    December 23, 2013
    Manufacturer
    ALCON PRECISION DEVICE - SINKING SPRING
    Product Code
    HNN
    PMA / PMN 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 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
    53646 KNIFE MANUAL OPHTHALMIC SURGICAL INSTRUMENT. HNN ALCON PRECISION DEVICE - SINKING SPRING 8065992745 929897M

    Patients

    Seq Age Sex Outcome Treatment
    1