BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KNIFE

    MDR report key: 3745449 · Received January 24, 2014

    Report

    Report Number
    2523835-2014-00005
    Event Type
    Malfunction
    Date Received
    January 24, 2014
    Date of Event
    December 30, 2013
    Report Date
    December 31, 2013
    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
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE OR LOT NUMBER INFORMATION HAS BEEN RECEIVED. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. ALL KNIVES ARE 100% INSPECTED BY TRAINED OPERATORS USING A MINIMUM OF (B)(4) MAGNIFICATION DURING MANUFACTURING. ANY DEFECTS, SUCH AS DAMAGED TIPS AND CUTTING EDGES, ARE REMOVED FROM THE LOT AND SCRAPPED. SHARPNESS TESTING IS PERFORMED AND MONITORED DURING THE FINISHING PROCESS TO ENSURE THE SHARPNESS OF THE PRODUCT. (B)(4).

    Description of Event or Problem · 1

    A CONSULTANT REPORTED THAT BLUNT KNIFE BLADES WITH DAMAGED TIPS WERE NOTED IN SURGERY. IN ALL CASES, AN ADDITIONAL KNIFE WAS NEEDED. THERE WAS NO IMPACT TO ANY PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57629 KNIFE MANUAL OPHTHALMIC SURGICAL INSTRUMENT HNN ALCON PRECISION DEVICE- SINKING SPRING 8065982665 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1