BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGACLIP RIGH ANGLE MULTIPLE CLIP APPLIER

    MDR report key: 179272 · Received July 27, 1998

    Report

    Report Number
    1527736-1998-02228
    Event Type
    Injury
    Date Received
    July 27, 1998
    Date of Event
    February 1, 1998
    Report Date
    July 13, 1998
    Manufacturer
    ORIGIN MEDSYSTEMS, INC.
    Product Code
    GDO
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE REP THE SURGEON USED A LAPAROSCOPIC CLIP APPLIER DURING THE CASE (EXACT EVENT AND PROCEDURE DATE UNKNOWN) TO SEAL THE CYSTIC DUCT AND ARTERY. THE CASE WAS COMPLETED WITH NO NOTICED PROBLEMS. IN RECOVERY, PT COMPLAINED OF MORE DIFFICULTY THAN NORMAL. WHEN CONDITION WORSENED, PT WAS BROUGHT BACK TO SURGERY. WHEN PT WAS OPENED IT WAS DISCOVERED THAT THE MOST PROXIMAL CLIP ON THE CYSTIC DUCT HAD COME OFF AND THERE WAS A SUBSEQUENT BILE LEAK. PT WAS REEXPLORED 24 HOURS AFTER INITIAL LAPAROSCOPIC PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGACLIP RIGH ANGLE MULTIPLE CLIP APPLIER CLIP APPLIER GDO ORIGIN MEDSYSTEMS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention