BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPLEX SYSTEM WITH VERTAPLEX HV W/O NEEDLES

    MDR report key: 4932631 · Received July 22, 2015

    Report

    Report Number
    0001811755-2015-02693
    Event Type
    Malfunction
    Date Received
    July 22, 2015
    Date of Event
    June 4, 2015
    Report Date
    June 23, 2015
    Manufacturer
    STRYKER INSTRUMENTS-PUERTO RICO
    Product Code
    JDZ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON EVALUATION OF THE RETURNED PRODUCT, THE REPORTED CONDITION WAS CONFIRMED TO BE RELATED TO A CEMENT LEAKAGE FAILURE. VISUAL INSPECTION DISCLOSED THE CEMENT LEAKAGE OCCURRED AT THE CONNECTION AREA BETWEEN THE LUER HOUSING AND LUER SPINDLE FROM THE EXTENSION TUBE ASSEMBLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE THERE WAS A LEAK BETWEEN THE CONNECTION OF THE TUBING AND THE BIOPSY NEEDLE. THERE WAS A 30 MINUTE DELAY TO OBTAIN ANOTHER UNIT. AS PER THE CUSTOMER NO MEDICAL INTERVENTION WAS NEEDED AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE THERE WAS A LEAK BETWEEN THE CONNECTION OF THE TUBING AND THE BIOPSY NEEDLE. THERE WAS A 30 MINUTE DELAY TO OBTAIN ANOTHER UNIT. AS PER THE CUSTOMER NO MEDICAL INTERVENTION WAS NEEDED AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    474928 AUTOPLEX SYSTEM WITH VERTAPLEX HV W/O NEEDLES MIXER, CEMENT, FOR CLINICAL USE JDZ STRYKER INSTRUMENTS-PUERTO RICO UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1