BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM PAK

    MDR report key: 3820103 · Received April 1, 2014

    Report

    Report Number
    3002037047-2014-00032
    Event Type
    Malfunction
    Date Received
    April 1, 2014
    Date of Event
    March 1, 2014
    Report Date
    March 13, 2014
    Manufacturer
    ALCON - BELGIUM / ALCON N.V.
    Product Code
    KYG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: NO SAMPLE HAS BEEN RECEIVED FOR EVALUATION. 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 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

    AN OPERATING ROOM SUPERVISOR REPORTED THAT TWO KNIVES DID NOT CUT DURING EITHER OF TWO PROCEDURES. IN EACH CASE, AN ALTERNATE KNIFE WAS USED TO CONTINUE THE PROCEDURE WITHOUT DELAY. THERE WAS NO PATIENT IMPACT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196410 CUSTOM PAK CONVENIENCE KIT KYG ALCON - BELGIUM / ALCON N.V. CUSTOM PAK 380984

    Patients

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