BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KNIFE

    MDR report key: 3038405 · Received April 2, 2013

    Report

    Report Number
    2523835-2013-00034
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    January 1, 2013
    Report Date
    March 8, 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
    NO
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS IN PROGRESS. SAMPLES HAVE NOT YET BEEN RECEIVED FOR EVAL. SINCE NO LOT NUMBER WAS PROVIDED, A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. A ROOT CAUSE HAS NOT BEEN IDENTIFIED. ALL KNIVES ARE 100% INSPECTED BY TRAINED OPERATOR USING A MINIMUM OF 10 X MAGNIFICATION DURING MFG. 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 CUSTOMER REPORTED THAT THE KNIFE WAS NOT AS SHARP AS IT SHOULD BE DURING SURGERY. WHEN THE CUSTOMER TRIED TO MAKE THE INCISION, THE KNIFE JUST PUSHED THE EYE FORWARD. THE CUSTOMER LOOKED AT THE KNIFE UNDER THE MICROSCOPE AND SAW THAT IT WAS NOT SHARP. THE KNIFE WAS EXCHANGED AND THE PROCEDURE WAS COMPLETED WITH NO PT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134824 KNIFE MANUAL OPHTHALMIC SURGICAL INSTRUMENT HNN ALCON PRECISION DEVICE - SINKING SPRING 8065982265 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 CLEARCUT HP2DB SLIT 2.2 MM ANGLED