BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOPROBE

    MDR report key: 7052475 · Received November 22, 2017

    Report

    Report Number
    3008492462-2017-00088
    Event Type
    Malfunction
    Date Received
    November 22, 2017
    Date of Event
    October 26, 2017
    Report Date
    October 26, 2017
    Manufacturer
    DEVICOR MEDICAL PRODUCTS, INC.
    Product Code
    IZD
    PMA / PMN Number
    510K EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE NEOPROBE NPB09S IS A REUSABLE GAMMA DETECTION PROBE THAT IS CLEANED AND DISINFECTED AND/OR STERILIZED BETWEEN USES. BASED ON REVIEW OF THE DHR, THE DEVICE WAS MANUFACTURED IN NOVEMBER 2014 AND RELEASED FOR COMMERCIAL USE HAVING MET ALL ACCEPTANCE TESTS AND CALIBRATION CRITERIA. THE DEVICE WAS RECEIVED AT THE SITE OF MANUFACTURER, NORTECH, ON NOVEMBER 2, 2017. THE DEVICE IS CURRENTLY IN THE EVALUATION PROCESS. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE EVALUATION IS COMPLETE. WHILE THERE WAS NO ADVERSE EFFECT DURING THIS EVENT, THERE IS A POTENTIAL FOR SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR. THIS POTENTIAL SERIOUS INJURY WOULD BE FROM AN INFECTION DUE TO CROSS CONTAMINATION AND/OR THE TIP OF THE NEOPROBE PROBE FALLING OFF DURING THE PROCEDURE AND BEING LEFT BEHIND IN THE BODY. POSSIBLE CAUSES OF THIS DEFECT WOULD BE DEFICIENT EPOXY OR A LOOSE PROBE TIP. BOTH OF THESE POTENTIAL SERIOUS INJURIES COULD REQUIRE A SUBSEQUENT SURGICAL PROCEDURE. PURSUANT TO 21 CFR 803, WE ARE DEEMING THIS A REPORTABLE EVENT AND THUS SUBMITTING THIS MEDWATCH REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SALES REP THAT PRIOR TO A PROCEDURE/DURING SET UP THE END OF THE PROBE HAD BROKEN OFF. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. NO PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    832324 NEOPROBE GAMMA UPTAKE PROBE IZD DEVICOR MEDICAL PRODUCTS, INC. NPB09S

    Patients

    Seq Age Sex Outcome Treatment
    1