BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM PAK

    MDR report key: 4210300 · Received May 2, 2014

    Report

    Report Number
    3002037047-2014-00053
    Event Type
    Malfunction
    Date Received
    May 2, 2014
    Report Date
    April 11, 2014
    Manufacturer
    ALCON - BELGIUM/ALCON 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
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLES HAVE BEEN RECEIVED BY MANUFACTURING THAT HAVE NOT YET BEEN EVALUATED. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFO BECOMES AVAILABLE. 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. ADDITIONAL INFORMATION HAS BEEN REQUESTED. (B)(4).

    Description of Event or Problem · 1

    A PHARMACIST REPORTED THAT THE KNIVES DID NOT CUT WELL DURING THREE SURGERIES. THE SURGERIES WERE DELAYED FOR ONLY MINUTES UNTIL ALTERNATE KNIVES WERE OBTAINED TO CONTINUE EACH PROCEDURE. THERE WAS NO HARM TO ANY PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266358 CUSTOM PAK CONVENIENCE KIT KYG ALCON - BELGIUM/ALCON N.V. CUSTOM PAK UNK

    Patients

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