BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KNIFE

    MDR report key: 2100634 · Received May 13, 2011

    Report

    Report Number
    2523835-2011-00042
    Event Type
    Malfunction
    Date Received
    May 13, 2011
    Date of Event
    April 6, 2011
    Report Date
    April 13, 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
    SC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DID NOT RETAIN SAMPLES FOR EVAL. THE DEVICE HISTORY RECORDS (DHR) FOR THE LOT WAS REVIEWED. FUNCTIONAL PENETRATION AND SHARPNESS TEST VALUES FOR THE LOT MET SPEC. NO ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO A DULL KNIFE WERE FOUND DURING THE DHR REVIEW AND THE PRODUCT WAS RELEASED ACCORDING TO MANUFACTURE ACCEPTANCE CRITERIA. THE ROOT CAUSE CANNOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED THAT DULL KNIFE BLADES WERE EXPERIENCED DURING MULTIPLE PROCEDURES. THERE WAS NO PT HARM OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KNIFE MANUAL OPHTHALMIC SURGICAL INSTRUMENT HNN ALCON PRECISION DEVICE - SINKING SPRING 8065992645 833226M

    Patients

    Seq Age Sex Outcome Treatment
    1