BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUCLIP

    MDR report key: 193262 · Received October 21, 1998

    Report

    Report Number
    2939738-1998-00016
    Event Type
    Injury
    Date Received
    October 21, 1998
    Date of Event
    August 1, 1998
    Report Date
    September 21, 1998
    Manufacturer
    ORIGIN MEDSYSTEMS, INC.
    Product Code
    GDO
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    UNDER EMERGENCY CONDITIONS, A RE-LAPAROTOMY PROCEDURE WAS PERFORMED VIA RIGHT PARARECTAL INCISION. LARGE QUANTITIES OF BLOOD WERE FOUND IN THE ABDOMINAL CAVITY AND COAGULATED BLOOD WERE FOUND IN THE ABDOMEN. AFTER CLEANING THE EXCESS BLOOD, THE STUMP OF THE CYSTIC ARTERY WAS FOUND TO BE LEAKING. TWO CLIPS WERE OBSERVED TO BE ATTACHED TO THE ARTERY, BUT DIDN'T APPEAR TO BE CLOSED COMPLETELY. THE CYSTIC DUCT WAS CLOSED WITH A DOUBLE LIGATURE, THE OTHER CYSTIC ARTERY WHICH WAS ALSO BLEEDING WAS LIGATED, AS WELL. AS A RESULT, COMPLETE HEMOSTASIS IS ACHIEVED. A TACHOCOMB IS INTRODUCED TO AVOID THE SLIGHTEST BLEEDING. A 30 ROBINSON DRAIN IS APPLIED AND THE WOUND IS THEN CLOSED IN LAYERS. UNTIL THE END OF THE OPERATION, 30 ROBINSON DRAIN ONLY EMITS DRAINAGE FLUID WITH LITTLE BLOOD. THE PATIENT WAS REPORTED AS IN GOOD CONDITION AND NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Life Threatening| R