BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGACLIP ERCP

    MDR report key: 25204 · Received January 18, 1995

    Report

    Report Number
    25204
    Event Type
    Injury
    Date Received
    January 18, 1995
    Date of Event
    December 8, 1994
    Report Date
    December 15, 1994
    Manufacturer
    ETHICON ENDO-SURGERY
    Product Code
    GDO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ROUTINE LAP CHOLE ERFORMED 11/29/94. PATIENT READMITTED 12/8/94 WITH A BILE DUCT LEAK. CLIPS FOUND IN PLACE, BUT LEAKING. READMITTOR AN ERCP AND STENT. DOCTOR REPORTED INCIDENT 12/13/94. 12/8 POST-OP WAS VERY FAVORABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGACLIP ERCP Implant LAPAROSCOPIC LIGATING CLIPS GDO ETHICON ENDO-SURGERY ER 320 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 65 * Hospitalization| R