BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 3002411 · Received March 8, 2013

    Report

    Report Number
    2134070-2013-00054
    Event Type
    Malfunction
    Date Received
    March 8, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 15, 2013
    Manufacturer
    STERILMED, INC.
    Product Code
    NLM
    PMA / PMN Number
    K052299
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL DEVICE INVESTIGATION FOUND THE DEVICE RETURNED WITH THE SLEEVE SNAPPED IN HALF MIDWAY DOWN ITS LENGTH, AND THE HANDLE OF THE OBTURATOR BROKEN INTO ITS COMPONENT PIECES. THE SLEEVE BREAK WAS MOSTLY CLEAN WITH ONLY ONE JAGGED AREA AND OCCURRED AT ONE OF THE RIDGES. AS NO PACKAGING WAS RETURNED, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. AS EACH DEVICE IS VISUALLY AND FUNCTIONALLY TESTED PRIOR TO RELEASE, NO CONCLUSION COULD BE DRAWN AS TO WHAT MAY HAVE CAUSED THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BOTTOM HALF OF THE DEVICE SHAFT THAT WAS INSERTED INTO THE PT BROKE OFF INSIDE THE PT DURING A THORACOTOMY. THE BROKEN PART HAD TO BE "FISHED OUT," AND THE SURGEON HAD TO ASK FOR MORE INSTRUMENTS TO DO SO. ALL OF THE PIECES WERE REMOVED, AND THE CASE WAS COMPLETED AS NORMAL. THERE WAS NO PT INJURY, BUT THE CASE WAS DELAYED FOR THE AMOUNT OF IT TOOK TO RETRIEVE THE BROKEN PIECE. THE EXACT AMOUNT OF TIME WAS NOT GIVEN. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO ADDITIONAL INFORMATION WAS RECEIVED. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS MADE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    99893 NA NLM STERILMED, INC. EHTB5LT

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR