BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KNIFE

    MDR report key: 2161129 · Received June 17, 2011

    Report

    Report Number
    2523835-2011-00080
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    May 18, 2011
    Report Date
    May 19, 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 Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLES WERE RETURNED FOR EVAL; THEREFORE, THE CONDITION OF THE PRODUCT COULD NOT BE VERIFIED. BECAUSE A SAMPLE WAS NOT RETURNED, THE ROOT CAUSE FOR THE DULL KNIFE EXPERIENCED BY THE CUSTOMER CANNOT BE DETERMINED. THE COMPLAINT RATE FOR THE PAST YEAR FOR DULL/DAMAGED/BLUNT KNIVES WAS REVIEWED. NO ADVERSE TRENDS IN COMPLAINT RATE HAVE BEEN OBSERVED. (B)(4).

    Description of Event or Problem · 1

    A HOSP PHARMACIST REPORTED THAT DURING SURGERY ON THREE DIFFERENT PTS, KNIVES EXHIBITED POOR CUTTING PERFORMANCE. NO PT IDENTIFIERS WERE PROVIDED AND NO HARM TO ANY PT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KNIFE MANUAL OPHTHALMIC SURGICAL INSTRUMENT HNN ALCON PRECISION DEVICE - SINKING SPRING 8065992245 832514M

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK