BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM PAK

    MDR report key: 3130326 · Received May 22, 2013

    Report

    Report Number
    1644019-2013-00058
    Event Type
    Malfunction
    Date Received
    May 22, 2013
    Date of Event
    April 24, 2013
    Report Date
    April 24, 2013
    Manufacturer
    ALCON - HOUSTON
    Product Code
    KYG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ONE OPENED SAMPLE WAS RETURNED. EVAL OF THE SAMPLE SHOWED THE FOLLOWING RESULTS: THE SAMPLE WAS EXAMINED USING 10X MAGNIFICATION AND FOUND TO HAVE A DAMAGED TIP AND CUTTING EDGES. THE DEVICE HISTORY RECORDS (DHR) FOR THE TWO POSSIBLE LOTS WERE REVIEWED. FUNCTIONAL PENETRATION TEST VALUES FOR THIS LOT MET SPECIFICATION. A BENT TIP REJECTION WAS FOUND DURING THE DHR REVIEW. HOWEVER, THE SUSPECT PRODUCT WAS RE-INSPECTED AND THE PRODUCT WAS RELEASED ACCORDING TO THE MFR'S ACCEPTANCE CRITERIA. HOW OR WHEN THE BLADE BECAME DAMAGED CANNOT BE DETERMINED. THE DAMAGE TO THE RETURNED SAMPLE IS CONSISTENT WITH DAMAGE THAT CAN OCCUR WHEN THE BLADE CONTACTS ANOTHER SURFACE PRIOR TO USE. SOME POTENTIAL CAUSES COULD BE REUSE, IMPROPER HANDLING, OR CONTACT WITH ANOTHER INSTRUMENT ON THE INSTRUMENT TRAY DURING PROCEDURE SET UP. 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 THAT WHILE LOOKING THROUGH THE MICROSCOPE, HE NOTICED THAT THE KNIFE HAD A BURR ON THE TIP. THE CUSTOMER WAS ABLE TO BEND THE BURR FLAT USING FORCEPS. THE CUSTOMER HAD TO USE INCREASED PRESSURE TO MAKE THE INCISION DURING SURGERY. THE PROCEDURE WAS COMPLETED WITH NO HARM TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227499 CUSTOM PAK CONVENIENCE KIT KYG ALCON - HOUSTON CUSTOM PAK 1378538H

    Patients

    Seq Age Sex Outcome Treatment
    1 CLEARCUT SIDE PORT 1.2 MM ANGLED KNIFE