BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUCLIP

    MDR report key: 203972 · Received December 28, 1998

    Report

    Report Number
    2939738-1998-00029
    Event Type
    Injury
    Date Received
    December 28, 1998
    Report Date
    November 25, 1998
    Manufacturer
    ORIGIN MEDSYSTEMS, INC.
    Product Code
    GCJ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE REPORT REC'D, INDICATES THAT AN INCIDENT HAS OCCURRED WHILE THE SURGEON PERFORMED A HYATAL HERNIA PROCEDURE. IT WAS REPORTED THAT THE ACUCLIP SHOWS DIFFICULTIES IN THE ADVANCEMENT OF THE CLIPS, WHICH THEN CAUSES THE CLIP TO REMAIN STUCK IN THE UNIT. THE CLIPS THEN ARE NOT CLOSING PROPERLY. ONCE THE DEVICE GETS STUCK, IT IS THEN NECESSARY TO PULL AND BREAK THE CLIPPED VESSEL. THE VESSEL ON A PT WAS REPORTED TO HAVE HEMORRHAGED AND THEN RUPTURED. THE CASE WAS COMPLETED WITH NO FURTHER COMPLICATIONS TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUCLIP ACUCLIP GCJ ORIGIN MEDSYSTEMS, INC. OMS-A8 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Required Intervention