BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KNIFE

    MDR report key: 2172644 · Received June 24, 2011

    Report

    Report Number
    2523835-2011-00095
    Event Type
    Malfunction
    Date Received
    June 24, 2011
    Date of Event
    May 26, 2011
    Report Date
    May 26, 2011
    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
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BECAUSE A SAMPLE WAS NOT RETURNED AND NO LOT NUMBER WAS PROVIDED, THE ROOT CAUSE FOR THE DULL KNIFE EXPERIENCED BY THE CUSTOMER CANNOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED THAT A DULL KNIFE WAS EXPERIENCED DURING SURGERY. THERE WAS NO HARM TO THE PT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KNIFE MANUAL OPHTHALMIC SURGICAL INSTRUMENT HNN ALCON PRECISION DEVICE - SINKING SPRING 8065921540 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK