BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM PAK

    MDR report key: 2915073 · Received December 20, 2012

    Report

    Report Number
    3002037047-2012-00175
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 20, 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
    IT
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLES WERE RETURNED FOR EVALUATION; 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 SPECIFICATION. NO ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO A BLUNT KNIFE WERE FOUND DURING THE DHR REVIEW AND THE PRODUCT WAS RELEASED ACCORDING TO THE MFR'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 BLUNT KNIFE EXPERIENCED BY THE CUSTOMER CANNOT BE DETERMINED. THE MOST LIKELY CAUSE OF BLUNTNESS IS DAMAGE TO BLADE. HOWEVER, BASED ON THE INFORMATION ABOVE IT IS UNLIKELY THAT THE DAMAGE OCCURRED DURING THE MANUFACTURING PROCESS. SOME POTENTIAL CAUSES ARE REUSE, IMPROPER HANDLING, OR CONTACT WITH ANOTHER INSTRUMENT ON THE INSTRUMENT TRAY DURING PROCEDURE SET-UP. BECAUSE THE EXACT ROOT CAUSE FOR THIS COMPLAINT IS UNKNOWN, SPECIFIC ACTION WITH REGARDS TO THIS COMPLAINT CANNOT BE TAKEN. 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. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED A BLUNT KNIFE FROM AN INSTRUMENT PACK, NOTED PRIOR TO THE PROCEDURE. THERE WAS NO PT INVOLVEMENT.

    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 327841

    Patients

    Seq Age Sex Outcome Treatment
    1 A-OK 22.G FULL HANDLE 1.65 MM