BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM PAK

    MDR report key: 2501221 · Received March 16, 2012

    Report

    Report Number
    3002037047-2012-00057
    Event Type
    Malfunction
    Date Received
    March 16, 2012
    Report Date
    February 14, 2012
    Manufacturer
    ALCON - BELGIUM/S.A. ALCON-COUVREUR 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
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLES WERE RETURNED FOR EVALUATION; THEREFORE, THE CONDITION OF THE PRODUCT COULD NOT BE VERIFIED. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTER DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. THE ROOT CAUSE FOR THE WHITE PARTICLES EXPERIENCED BY THE CUSTOMER COULD NOT BE DETERMINED. ALL KNIVES ARE 100% INSPECTED BY TRAINED OPERATORS USING A MINIMUM OF 10X MAGNIFICATION DURING MANUFACTURING. ANY DEFECTS, SUCH AS WHITE PARTICLES, ARE REMOVED FROM THE LOT AND SCRAPPED. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED WHITE PARTICLES WERE REMOVED FROM SEVERAL PT'S EYES DURING SURGERY. THE DOCTOR SUSPECTS FOAM FROM THE KNIFE PACKAGING COULD BE THE CAUSE AS THE FOAM STICKS TO THE KNIFE. THERE WAS NO HARM REPORTED. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 CLEARCUT SB INTREPID 2.2 ANG| CLEARCUT SATINSLIT FULL HANDLE