BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 3002419 · Received March 8, 2013

    Report

    Report Number
    2134070-2013-00048
    Event Type
    Malfunction
    Date Received
    March 8, 2013
    Report Date
    February 8, 2013
    Manufacturer
    STERILMED, INC.
    Product Code
    NLM
    PMA / PMN Number
    K012578
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT IF THE DEVICE IS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEVER REGULATING THE GAS WAS LOOSE AND OPENED ON IT OWN DURING SURGERY, RESULTING IN A LOSS OF CO2. THE DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED. THE PROCEDURE WAS EITHER A VIDEO LAPAROSCOPIC CHOLECYSTECTOMY OR VIDEO LAPAROSCOPIC APPENDECTOMY. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98973 NA NLM STERILMED, INC. AUT177092F

    Patients

    Seq Age Sex Outcome Treatment
    1