BEUDAMED
    FDA Adverse Event Summary report: N

    ETHICON

    MDR report key: 2940802 · Received January 30, 2006

    Report

    Report Number
    2940802
    Date Received
    January 30, 2006
    Date of Event
    January 17, 2006
    Report Date
    January 27, 2006
    Manufacturer
    ETHICON ENDO
    Product Code
    FZP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT UNDERWENT LAPAROSCOPIC CHOLECYSTECTOMY ON (B)(6) 2006, WHERE SURGEON USED CLIPS TO CLOSE OF COMMON BILE DUCT. PT STABLE AND DISCHARGED POST PROCEDURE, BUT RETURNED 2 DAYS ON (B)(6) 2006 WITH ABDOMINAL PAIN, NAUSEA. UNDERWENT EXPLORATORY LAP WHICH REVEALED LEAKING COMMON BILE DUCT WITH OBVIOUS DISRUPTED CLIP UNDER DUCT RATHER THAN ON END OF DUCT, APPROX 2 L BILE IN ABDOMEN. ABDOMEN IRRIGATED, CYSTIC STUMP DUCT LIGATED AND CLIPPED, PT STABILIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHICON ETHICON CLIP APPLIER FZP ETHICON ENDO UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention