BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM PAK

    MDR report key: 4062765 · Received August 20, 2014

    Report

    Report Number
    3002037047-2014-00099
    Event Type
    Malfunction
    Date Received
    August 20, 2014
    Date of Event
    July 29, 2014
    Report Date
    July 29, 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
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A SAMPLE HAS BEEN RECEIVED BY MANUFACTURING THAT HAS 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 INFORMATION 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 FORM 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 DOCTOR REPORTED THAT A BLUNT KNIFE WAS EXPERIENCED DURING SURGERY. AN ALTERNATE KNIFE HAD TO BE OBTAINED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO IMPACT TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504055 CUSTOM PAK CONVENIENCE KIT KYG ALCON - BELGIUM/ALCON N.V. CUSTOM PAK 396121

    Patients

    Seq Age Sex Outcome Treatment
    1 A-OK 22.5D FULL HANDLE 1.65MM