BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PNEUMOPERITONEUM NEEDLE

    MDR report key: 102476 · Received June 28, 1997

    Report

    Report Number
    2939738-1997-00021
    Event Type
    Malfunction
    Date Received
    June 28, 1997
    Report Date
    May 29, 1997
    Manufacturer
    ORIGIN MEDSYSTEMS, INC.
    Product Code
    FHO
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A LAPAROSCOPIC PROCEDURE, THE SPRING STYLET ON THE PNEUMONEEDLE FAILED TO RETURN TO ITS PROPER POSITION, THEREFORE EXPOSING THE NEEDLE END. THE INVESTIGATION IS STILL IN PROGRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PNEUMOPERITONEUM NEEDLE PHEUMOPERITONEUM NEEDLE FHO ORIGIN MEDSYSTEMS, INC. OMS-N120 2003971

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN