BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    777401 EPUMP ENPLUS SPIKE SET X30

    MDR report key: 9505861 · Received December 20, 2019

    Report

    Report Number
    9611018-2019-00378
    Event Type
    Malfunction
    Date Received
    December 20, 2019
    Date of Event
    September 7, 2019
    Report Date
    December 20, 2019
    Manufacturer
    COVIDIEN
    Product Code
    FHX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE FOR THIS EVENT.  AS PART OF OUR MANUFACTURING PROCESS, ALL DEVICE HISTORY RECORDS ARE REVIEWED AND APPROVED BY QUALITY, PRIOR TO RELEASE OF PRODUCT.  IF ADDITIONAL INFORMATION OR THE SAMPLE IS RECEIVED, THE INVESTIGATION WILL BE REOPENED AND RESPONDED TO ACCORDINGLY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING USE, THERE WAS A LEAK NOTICED AROUND THE ENFIT CONNECTOR. THERE IS NO KNOWN CONSEQUENCE TO THE PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1302740 777401 EPUMP ENPLUS SPIKE SET X30 JELLY, LUBRICATING, FOR TRANSURETHRAL SURGICAL INSTRUMENT FHX COVIDIEN 777401 18J241FHX

    Patients

    Seq Age Sex Outcome Treatment
    1