BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM PAK

    MDR report key: 2081347 · Received April 22, 2011

    Report

    Report Number
    1644019-2011-00018
    Event Type
    Malfunction
    Date Received
    April 22, 2011
    Date of Event
    February 22, 2011
    Report Date
    February 22, 2011
    Manufacturer
    ALCON - HOUSTON
    Product Code
    KYG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 SHARPNESS TEST VALUES FOR THE LOT MET SPEC. NO ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO A DULL KNIFE WERE FOUND DURING THE DHR REVIEW AND THE PRODUCT WAS RELEASED ACCORDING TO ALCON'S ACCEPTANCE CRITERIA. BECAUSE A SAMPLE WAS NOT RETURNED AND NO EVIDENCE OF NONCONFORMITY COULD BE FOUND IN THE LOT RECORD REVIEW, THE ROOT CAUSE FOR THE DULL KNIFE EXPERIENCED BY THE CUSTOMER CANNOT BE DETERMINED. 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. SHARPNESS TESTING IS PERFORMED AND MONITORED DURING THE FINISHING PROCESS TO ENSURE THE SHARPNESS OF THE PRODUCT. COMPLAINTS ARE REVIEWED AND MONITORED AT REGULAR INTERVALS FOR ANY SIGNIFICANT ADVERSE TRENDS. NO ADD'L ACTION IS REQUIRED AT THIS TIME. (B)(4). THIS REPORT WAS MAILED TO FDA ON: 04/22/2011. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED DURING A PROCEDURE A DULL KNIFE WAS NOTED. SHE STATED THAT THE PHYSICIAN FELT LIKE THE KNIFE WAS DULLER THAN USUAL. THE PHYSICIAN FELT THAT THE STERILIZATION PROCESS OF THE SURGICAL PACKS MAY HAVE AFFECTED THE BLADE. THERE WAS NO PT IMPACT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUSTOM PAK CONVENIENCE KIT KYG ALCON - HOUSTON CUSTOM PAK 828690M

    Patients

    Seq Age Sex Outcome Treatment
    1