BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAPAROSCOPE

    MDR report key: 5107328 · Received September 28, 2015

    Report

    Report Number
    5107328
    Event Type
    Malfunction
    Date Received
    September 28, 2015
    Date of Event
    September 10, 2015
    Report Date
    September 17, 2015
    Manufacturer
    APPLIED MEDICAL RESOURCES CORP
    Product Code
    HET
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SURGEON WAS USING A GELPORT DEVICE AND WHILE THE DEVICE WAS DEPLOYED IN THE ABDOMINAL CAVITY OF THE PATIENT, THE CLEAR PLASTIC RIPPED WHILE SURGEON WAS USING DEVICE. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT. PROTOCOL FOLLOWED FOR POSSIBLE RETAINED FOREIGN BODY. NO HARM TO PATIENT, A NEW GELPORT DEVICE WAS OPENED AND PROCEDURE CONCLUDED WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    638295 LAPAROSCOPE HET APPLIED MEDICAL RESOURCES CORP C8XX2 1249262

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR