BEUDAMED
    FDA Adverse Event Death Summary report: N

    ACU CLIP RIGHT-ANGLE CLIP APPLIER

    MDR report key: 424577 · Received October 25, 2002

    Report

    Report Number
    2647580-2002-00227
    Event Type
    Death
    Date Received
    October 25, 2002
    Date of Event
    September 18, 2002
    Report Date
    September 27, 2002
    Manufacturer
    PONCE - USS
    Product Code
    GDO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE: LAPAROSCOPIC CHOLECYSTECTOMY. REPORTEDLY, SEVERAL HOURS AFTER THE INITIAL SURGERY, THE PT DEVELOPED A SUDDEN CHANGE IN CONDITION, I.E. HYPOTENSION. A RE-OPERATION WAS DONE AND IT WAS NOTED THAT THE CLIP HAD COME OFF THE CYSTIC ARTERY. THE INSTRUMENT USED IN THE FIRST SURGERY WAS A RESTERILIZED (ETO) DISPOSABLE SINGLE USE INSTRUMENT. NO FURTHER INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACU CLIP RIGHT-ANGLE CLIP APPLIER ENDOSCOPIC CLIP APPLIER GDO PONCE - USS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death