BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 3960171 · Received June 24, 2014

    Report

    Report Number
    2134070-2014-00125
    Event Type
    Malfunction
    Date Received
    June 24, 2014
    Date of Event
    May 22, 2014
    Report Date
    May 29, 2014
    Manufacturer
    STERILMED, INC.
    Product Code
    NMJ
    PMA / PMN Number
    K033579
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MFR AS OF THE DATE OF THIS REPORT AND WAS REPORTED TO HAVE BEEN DISCARDED BY THE USER FACILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY THE JAWS OF THE DEVICE SCISSORED, NOT ALLOWING CLIP TO FORM PROPERLY. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PT INJURY. ADDITIONAL INFO WAS REQUESTED, BUT NO ADDITIONAL INFO WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SENT IF ADDITIONAL INFO IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367172 NA NMJ STERILMED, INC. ETHER420

    Patients

    Seq Age Sex Outcome Treatment
    1