BEUDAMED
    FDA Adverse Event Other Summary report: N

    *

    MDR report key: 787370 · Received November 7, 2006

    Report

    Report Number
    9611112-2006-00004
    Event Type
    Other
    Date Received
    November 7, 2006
    Manufacturer
    *
    Product Code
    JYG
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: THE INSTRUMENT IN QUESTION WAS MANUFACTURED IN A LOT OF 25 PCS IN 2005 AND DELIVERED TO THE DISTRIBUTOR THE SAME DAY. BASED ON OUR TREND ANALYSIS RECORDS, WHICH ALLOW US TO TRACE BACK TO JANUARY 2003, WE HAVE NEVER RECEIVED A COMPLAINT OF THIS NATURE. A THOROUGH REVIEW OF OUR PRODUCTION RECORDS CONFIRMS THAT THE RIGHT MATERIALS HAD BEEN USED AND THAT THE INSTRUMENTS HAD BEEN MANUFACTURED ACCORDING TO DESIGN (MASTER SAMPLE) AND PRODUCTIONS SPECIFICATIONS RECEIVED FROM THE DISTRIBUTOR. AS PART OF THE INVESTIGATION WE ALSO PERFORMED IS A HARDENING TEST. THE HARDENING PROTOCOL SHOWS THE MEASURED HARDNESS OF 54,8 HRC (AVERAGE VALUE) IS WITHIN THE RANGE OF TOLERANCE OF HRC 48 - 56. CONCLUSION: NO DEFINITE CONCLUSION, FOR THE EXACT CAUSE OF THIS BREAK CAN BE DRAWN. BASED ON OUR LONGTERM EXPERIENCE AS QUALIFIED SURGICAL INSTRUMENT MFR, WE ARE OF THE OPINION THAT, THE OCCURRENCE OF A BREAK IN THIS AREA DURING SURGICAL APPLICATION CAN BE EXCLUDED. HOWEVER, IT IS WITHIN THE REALM OF POSSIBILITY THAT THE CUP COULD BREAK OFF DURING THE CLEANING AND STERILIZATION PROCESS, FOR INSTANCE, WHEN THE INSTRUMENT TIP GETS CAUGHT IN OR IS PICKED UP UNCAUTIOUSLY FROM THE STERILIZATION TRAY. AS STATED ABOVE, OUR PRODUCTION RECORDS INDICATE COMPLIANCE WITH ALL SPECIFICATIONS AND OUR TREND ANALYSIS REFLECTS NO PROBLEM WITH THIS PATTERN. THUS, WE FEEL THAT NO CORRECTIVE OR PREVENTIVE ACTION IS REQUIRED ON OUR PART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * * JYG * * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *