BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NA

    MDR report key: 3883784 · Received June 10, 2014

    Report

    Report Number
    2134070-2014-00122
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    May 9, 2014
    Report Date
    May 13, 2014
    Manufacturer
    STERILMED, INC.
    Product Code
    NUJ
    PMA / PMN Number
    K120040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MFR AS OF THE DATE OF THIS REPORT. A SUPPLEMENTAL REPORT WILL BE SENT AFTER EVAL IF THE DEVICE IS REC'D.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN OPEN COLECTOMY POST ACTIVATION AND UPON OPENING OF THE DEVICE, TISSUE CONSISTENTLY STUCK TO THE JAWS CAUSING ADD'L BLEEDING AND BREAKING SEAL ON VESSELS. THE STICKING BEGAN IMMEDIATELY POST ACTIVATION AFTER THE FIRST CLOSE/ACTIVATE/ACTIVATE/CUT SEQUENCE. NO ERROR TONES WERE EXPERIENCED. THE VESSELS THAT WERE COMPROMISED WERE EASILY CLAMPED AND SUTURED. A SIMILAR DEVICE OF A DIFFERENT MODEL NUMBER AND MFR WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE PT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343444 NA NUJ STERILMED, INC. COVLF4200

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention