BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PNEUMOPERITONEUM NEEDLE

    MDR report key: 105645 · Received July 11, 1997

    Report

    Report Number
    2939738-1997-00026
    Event Type
    Malfunction
    Date Received
    July 11, 1997
    Report Date
    June 11, 1997
    Manufacturer
    ORIGIN MEDSYSTEMS, INC.
    Product Code
    FHO
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A LAPAROSCOPIC HERNIA REPAIR, THE NEEDLE STYLET ALLEGEDLY DID NOT RETURN TO ITS PROPER PLACE TO COVER THE NEEDLE. ROOT CAUSE HAS NOT BEEN DETERMINED YET, INVESTIGATION IS STILL IN PROGRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PNEUMOPERITONEUM NEEDLE PNEUMOPERITONEUM NEEDLE FHO ORIGIN MEDSYSTEMS, INC. OMS-N120 0503971

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN