BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PNEUMOPERITONEUM NEEDLE

    MDR report key: 105640 · Received July 9, 1997

    Report

    Report Number
    2939738-1997-00024
    Event Type
    Malfunction
    Date Received
    July 9, 1997
    Report Date
    June 9, 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

    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 GYNECOLOGICAL PROCEDURE, THE NEEDLE'S STYLET ALLEGEDLY DID NOT RETURN TO ITS PROPER POSITION TO COVER THE NEEDLE. THE INVESTIGATION IS STILL PROGRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PNEUMOPERITONEUM NEEDLE PNEUMOPERITONEUM NEEDLE FHO ORIGIN MEDSYSTEMS, INC. OMS-N120 0804971

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN