BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM PAK

    MDR report key: 2467716 · Received February 17, 2012

    Report

    Report Number
    1644019-2012-00007
    Event Type
    Malfunction
    Date Received
    February 17, 2012
    Report Date
    January 18, 2012
    Manufacturer
    ALCON - HOUSTON
    Product Code
    KYG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLES WERE RETURNED FOR EVAL; THEREFORE, THE CONDITION OF THE PRODUCT COULD NOT BE VERIFIED. THE DEVICE HISTORY RECORD (DHR) FOR THE LOT WAS REVIEWED. FUNCTIONAL PENETRATION AND SHARPNESS. TEST VALUES FOR THE LOT MET SPECIFICATION. THE ROOT CAUSE CANNOT BE DETERMINED. ALL KNIVES ARE 100% INSPECTED BY TRAINED OPERATORS USING A MINIMUM OF 10X MAGNIFICATION DURING MANUFACTURING. PENETRATION AND SHARPNESS TESTING ARE PERFORMED AND MONITORED DURING THE FINISHING PROCESS TO ENSURE THE SHARPNESS OF THE PRODUCT. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED THAT DURING SURGERY, THEY EXPERIENCED DULL KNIVES WITH AN UNKNOWN NUMBER OF PTS. ALTERNATE KNIVES WERE USED TO COMPLETE THE PROCEDURES. NO PT HARM WAS REPORTED. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUSTOM PAK CONVENIENCE KIT KYG ALCON - HOUSTON CUSTOM PAK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 CLEARCUT HP2 DB SLIT 2.8MM ANG