BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PNEUMOPERITONEUM NEEDLE

    MDR report key: 110753 · Received August 1, 1997

    Report

    Report Number
    2939738-1997-00029
    Event Type
    Malfunction
    Date Received
    August 1, 1997
    Report Date
    July 3, 1997
    Manufacturer
    ORIGIN MEDSYSTEMS, INC.
    Product Code
    FHO
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    SERVICE PERSONNEL

    Narratives

    Description of Event or Problem · 1

    DURING A LAPAROSCOPIC PROCEDURE, THE NEEDLE STYLET ALLEGEDLY FAILED TO RETURN TO ITS PROPER PLACE TO COVER THE NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PNEUMOPERITONEUM NEEDLE PNEUMOPERITONEUM NEEDLE FHO ORIGIN MEDSYSTEMS, INC. OMS-N120 0704971

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other