BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM PAK

    MDR report key: 3022949 · Received March 20, 2013

    Report

    Report Number
    1644019-2013-00027
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    February 1, 2013
    Report Date
    March 4, 2013
    Manufacturer
    ALCON - HOUSTON
    Product Code
    KYG
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE WERE RETURNED FOR EVALUATION; THEREFORE, THE CONDITION OF THE PRODUCT COULD NOT BE VERIFIED. THE DEVICE HISTORY RECORD (DHR) FOR THE LOT WAS REVIEWED. FUNCTIONAL PENETRATION TEST VALUES FOR THE LOT MET SPECIFICATION. NO ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO A DULL KNIFE WERE FOUND DURING THE DHR REVIEW AND THE PRODUCT WAS RELEASED ACCORDING TO THE MFR'S ACCEPTANCE CRITERIA. BECAUSE A SAMPLE WAS NOT RETUNED AND NO EVIDENCE OF NONCONFORMITY COULD BE FOUND IN THE LOT RECORD REVIEW, THE ROOT CAUSE FOR THE DULL KNIFE EXPERIENCED BY THE CUSTOMER CAN NOT BE DETERMINED. SOME POTENTIAL CAUSES ARE REUSE, IMPROPER HANDLING, OR CONTACT WITH ANOTHER INSTRUMENT ON THE INSTRUMENT TRAY DURING PROCEDURE SETUP. ALL KNIVES ARE 100% INSPECTED BY TRAINED OPERATORS USING A MINIMUM OF 10X MAGNIFICATION DURING MFG. ANY DEFECTS SUCH AS DAMAGED TIPS AND CUTTING EDGES, ARE REMOVED FROM THE LOT AND SCRAPPED. PENETRATION 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 DURING A PROCEDURE, THE KNIFE WAS NOT CUTTING. THE PROCEDURE WAS COMPLETED WITH A BACKUP KNIFE. THERE WAS NO PT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116754 CUSTOM PAK CONVENIENCE KIT KYG ALCON - HOUSTON CUSTOM PAK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK CLEARCUT SIDEPORT FULL HANDLE