BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KNIFE

    MDR report key: 2092181 · Received April 27, 2011

    Report

    Report Number
    2523835-2011-00036
    Event Type
    Malfunction
    Date Received
    April 27, 2011
    Date of Event
    March 25, 2011
    Report Date
    March 28, 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
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLES WERE RETURNED FOR EVAL; THEREFORE, THE CONDITION OF THE PRODUCT COULD NOT BE VERIFIED. THE DEVICE HISTORY RECORD (DHR) FOR THE LOT WAS REVIEWED. FUNCTIONAL PENETRATION TEST VALUES FOR THE LOT MET SPECIFICATION. NO ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO A DULL KNIFE WERE FOUND DURING THE DHR REVIEW AND THE PRODUCT WAS RELEASED ACCORDING TO MFR ACCEPTANCE CRITERIA. THE ROOT CAUSE CANNOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL PHARMACIST REPORTED DURING A PROCEDURE, THE KNIFE WAS NOTED TO HAVE POOR CUTTING PERFORMANCE. ANOTHER KNIFE WAS USED TO COMPLETE THE CASE WITHOUT PT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KNIFE MANUAL OPHTHALMIC SURGICAL INSTRUMENT HNN ALCON PRECISION DEVICE - SINKING SPRING 8065982265 824584M

    Patients

    Seq Age Sex Outcome Treatment
    1