BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GELPORT 120MM

    MDR report key: 3131481 · Received February 25, 2013

    Report

    Report Number
    2027111-2013-00053
    Event Type
    Malfunction
    Date Received
    February 25, 2013
    Date of Event
    April 12, 2012
    Report Date
    February 22, 2013
    Manufacturer
    APPLIED MEDICAL
    Product Code
    GAD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT WAS NOT REPORTED TO APPLIED MEDICAL. WE LOCATED THIS REPORT ON A MAUDE REPORT WEBSITE; HOWEVER, THE MAUDE REPORT DID NOT CONTAIN THE HOSPITAL NAME HENCE WE COULD NOT REQUEST MORE INFORMATION OR THE RETURN OF THE EVENT SAMPLE FOR OUR INVESTIGATION. A DEVICE HISTORY REPORT OF THE INCIDENT WILL BE CONDUCTED AND A FOLLOW-UP REPORT WILL BE SENT UPON COMPLETION OF THE EVALUATION.

    Description of Event or Problem · 1

    "DURING THE PROCEDURE AND WHILE USING THE GELPORT LAPAROSCOPIC SYSTEM, THE GEL SEPARATED FROM THE RING AND INSUFFLATION WAS LEAKING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81151 GELPORT 120MM NONE GAD APPLIED MEDICAL C8XX2NONCE 1166832

    Patients

    Seq Age Sex Outcome Treatment
    1