BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 3950787 · Received June 9, 2014

    Report

    Report Number
    2134070-2014-00115
    Event Type
    Malfunction
    Date Received
    June 9, 2014
    Date of Event
    May 16, 2014
    Report Date
    May 16, 2014
    Manufacturer
    STERILMED, INC.
    Product Code
    NLM
    PMA / PMN Number
    K121240
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL DEVICE INVESTIGATION FOUND THAT THE DEVICE WAS RETURNED IN GOOD VISUAL CONDITION. UPON EVAL, THE STOPCOCK LEVER WAS SECURELY FASTENED AND HAD SUFFICIENT FRICTION TO PREVENT UNINTENDED MOVEMENT. THE DEVICE WAS THEN PRESSURE TESTED. THE DEVICE SHOWED NO SIGNS OF LEAKING BOTH WITH AND WITHOUT THE OBTURATOR INSERTED INTO THE SLEEVE. THE DEVICE HISTORY RECORD WAS REVIEWED, AND NO DISCREPANCIES WERE NOTED. AS THE DEVICE MET ALL VISUAL AND FUNCTIONAL TESTING CRITERIA, NO CONCLUSION COULD BE MADE AS TO WHAT MAY HAVE CAUSED THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC GYN ROBOT CASE THE DEVICE WAS LEAKING. THE DEVICE WAS NOT REPLACED, BUT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PT INJURY. .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334439 NA NLM STERILMED, INC. ETH2B5LT 1761497

    Patients

    Seq Age Sex Outcome Treatment
    1