BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KNIFE

    MDR report key: 2150675 · Received June 22, 2011

    Report

    Report Number
    2523835-2011-00089
    Event Type
    Malfunction
    Date Received
    June 22, 2011
    Report Date
    June 1, 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
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLES WERE RETURNED FOR EVALUATION; THEREFORE, THE CONDITION OF THE PRODUCT COULD NOT BE VERIFIED. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTER DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. 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. 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 SURGEON REPORTED THAT THE KNIVES FROM THE PACK ARE NOT SHARP AND OFTEN HAS TO REQUEST ANOTHER KNIFE IN ORDER TO COMPLETE THE CASE. THERE WAS NO HARM OR INJURY TO THE PTS INVOLVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1