BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM PAK

    MDR report key: 2427340 · Received January 5, 2012

    Report

    Report Number
    3002037047-2012-00001
    Event Type
    Malfunction
    Date Received
    January 5, 2012
    Date of Event
    January 1, 2011
    Report Date
    December 6, 2011
    Manufacturer
    ALCON-BELGIUM/S.A. ALCON-COUVREUR N.V.
    Product Code
    KYG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLES WERE RETURNED FOR EVAL; 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. THE ROOT CAUSE COULD NOT BE DETERMINED. THERE HAVE BEEN NO CHANGES IN THE MANUFACTURING PROCESS THAT WOULD CONTRIBUTE TO DAMAGED BLADES. ALL KNIVES ARE 100% INSPECTED BY TRAINED OPERATORS USING A MINIMUM OF 10X 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 NURSE REPORTED THAT THE SURGEON EXPERIENCED POOR CUTTING PERFORMANCE DURING SURGERY. AN ALTERNATE KNIFE WAS USED TO COMPLETE THE CASE WITHOUT HARM TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUSTOM PAK CONVENIENCE KIT KYG ALCON-BELGIUM/S.A. ALCON-COUVREUR N.V. CUSTOM PAK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 CLEARCUT HP2 DB SLIT 2.2MM ANG