BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAPAROSCOPE, REPROCESSED

    MDR report key: 4152541 · Received October 6, 2014

    Report

    Report Number
    2134070-2014-00174
    Event Type
    Malfunction
    Date Received
    October 6, 2014
    Date of Event
    September 8, 2014
    Report Date
    September 9, 2014
    Manufacturer
    STERILMED, INC.
    Product Code
    NLM
    PMA / PMN Number
    K121240
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RECEIVED AT THE MANUFACTURER'S FACILITY AS OF THE DATE OF THIS REPORT. A SUPPLEMENTAL REPORT WILL BE SENT FOLLOWING INVESTIGATION AFTER THE DEVICE IS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC J-TUBE PLACEMENT TOW DEVICE SLEEVES LEAKED CO2 AND CAUSING A LOSS OF PNEUMOPERITONEUM. THE DEVICE WAS LEAKING FROM THE TOP. FOR ONE OR BOTH DEVICES, A PRESTIGE WAS INSERTED INTO THE DEVICE BUT AFTER IT WAS NOTICED OT BE LEAKING. NO TORQUE WAS BEING PLACED ON THE DEVICE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY. SEE RELATED MFR. REPORT # 2134070-2014-000173.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622123 LAPAROSCOPE, REPROCESSED NLM STERILMED, INC. ETH2CB5LT 1789249

    Patients

    Seq Age Sex Outcome Treatment
    1