BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PNEUMOPERITONEUM NEEDLE

    MDR report key: 103808 · Received July 3, 1997

    Report

    Report Number
    2939738-1997-00022
    Event Type
    Malfunction
    Date Received
    July 3, 1997
    Report Date
    June 4, 1997
    Manufacturer
    ORIGIN MEDSYSTEMS, INC.
    Product Code
    FHO
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALL SUSPECTED UNITS HAVE BEEN RECALLED. THE REPORTED PROBLEM HAS BEEN CORRECTED BY MODIFICATIONS MADE TO THE MFG PROCESS.

    Description of Event or Problem · 1

    DURING A LAPAROSCOPIC PROCEDURE, THE STYLET DID NOT ALLEGEDLY RETURN TO ITS CORRECT POSITION TO COVER THE NEEDLE FROM EXPOSURE. THE CUSTOMER DIDN'T RETURN THE PRODUCT FOR AN EVAL. THE INVESTIGATION IS STILL IN PROGRESS. A FOLLOW-UP REPORT WILL BE SUBMITTED AT A LATER DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PNEUMOPERITONEUM NEEDLE PNEUMOPERITONEUM NEEDLE FHO ORIGIN MEDSYSTEMS, INC. OMS-N150 1001971

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other