BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KNIFE

    MDR report key: 2150658 · Received June 22, 2011

    Report

    Report Number
    2523835-2011-00093
    Event Type
    Malfunction
    Date Received
    June 22, 2011
    Report Date
    May 23, 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

    THE INVESTIGATION IS IN PROGRESS. SAMPLES HAVE NOT YET BEEN RECEIVED FOR EVALUATION. 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 COMPANY'S ACCEPTANCE CRITERIA. THE ROOT CAUSE HAS NOT BEEN IDENTIFIED. (B)(4).

    Description of Event or Problem · 1

    A PHARMACIST REPORTED DURING SURGERY, THE KNIFE WAS NOTED TO HAVE HAD POOR CUTTING PERFORMANCE. A SECOND KNIFE WAS USED AND THE PROCEDURE WAS COMPLETED. THERE WAS NO PT IMPACT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KNIFE MANUAL OPHTHALMIC SURGICAL INSTRUMENT HNN ALCON PRECISION DEVICE - SINKING SPRING 8065982265 831017M

    Patients

    Seq Age Sex Outcome Treatment
    1