BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 3123982 · Received May 15, 2013

    Report

    Report Number
    2134070-2013-00109
    Event Type
    Malfunction
    Date Received
    May 15, 2013
    Date of Event
    March 26, 2013
    Report Date
    April 3, 2013
    Manufacturer
    STERILMED, INC.
    Product Code
    NLM
    PMA / PMN Number
    K111002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL DEVICE INVESTIGATION FOUND THAT THE DEVICE WAS RETURNED WITH THE SEAL CAP AREA CRACKED OPEN AT THE SEAM, BUT STILL ATTACHED TO THE REST OF THE DEVICE. UPON FUNCTIONAL EVAL, THE DEVICE SHOWED SIGNS OF LEAKING BOTH WITH AND WITHOUT THE OBTURATOR INSERTED INTO THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TOP PART (CAP) OF THE DEVICE SLEEVE CAME OFF IN THE MIDDLE OF THE PROCEDURE WHICH WAS A LAPAROSCOPIC SUPRA CERVICAL HYSTERECTOMY. IT COULD NOT SNAP BACK TOGETHER AND APPEARED BROKEN. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PT INJURY. THIS REPORT IS BEING FILED FOR THE FINDINGS UPON DEVICE INVESTIGATION. ADD'L INFO WAS REQUESTED, BUT NO ADD'L INFO WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214544 NA NLM STERILMED, INC. APPCTB73 1413778

    Patients

    Seq Age Sex Outcome Treatment
    1