BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KNIFE

    MDR report key: 3043013 · Received March 7, 2013

    Report

    Report Number
    2523835-2013-00022
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Date of Event
    February 4, 2013
    Report Date
    February 5, 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
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS IN PROGRESS. SAMPLES HAVE BEEN RECEIVED AND IN-HOUSE TESTING IS IN PROGRESS. THE DEVICE HISTORY RECORD (DHR) FOR THE LOT WAS REVIEWED. FUNCTIONAL PENETRATION AND SHARPNESS TEST VALUES FOR THE LOT MET SPECIFICATION. NO ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO A BLUNT KNIFE WERE FOUND DURING THE DHR REVIEW AND THE PRODUCT WAS RELEASED ACCORDING TO MANUFACTURER'S ACCEPTANCE CRITERIA. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT MULTIPLE PHACO LANCES WERE BLUNT DURING SURGERIES. THE PROCEDURES WERE COMPLETED WITH THE LANCES BUT ADDITIONAL FORCE HAD TO BE USED IN ORDER TO MAKE THE INCISION. THERE WAS NO PT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98371 KNIFE MANUAL OPTHALMIC SURGICAL INSTRUMENT HNN ALCON PRECISION DEVICE - SINKING SPRING 8065993047 863469M

    Patients

    Seq Age Sex Outcome Treatment
    1