BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOPATH DILATING TIP TROCAR

    MDR report key: 99176 · Received June 20, 1997

    Report

    Report Number
    1527736-1997-01357
    Event Type
    Injury
    Date Received
    June 20, 1997
    Date of Event
    April 14, 1997
    Report Date
    June 18, 1997
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GCJ
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    5/21/97 RECEIVED VOLUNTARY MEDWATCH REPORT (ACCESS NUMBER #1011226) FROM USER FACILITY STATING "LAPAROSCOPIC CHOLECYSTECTOMY BEING PERFORMED. THERE APPEARED TO BE BILE LEAKAGE SO CONVERTED TO OPEN PROCEDURE. FOUND LINEAR LACERATION IN A LONGITUDINAL DIRECTION AT THE SITE OF THE CYSTIC DUCT AND THE COMMON DUCT JUNCTIVE WHICH REQUIRED SURGICAL REPAIR. PROLONGED SURGICAL PROCEDURE (6 3/4 HR.), PROLONGED HOSPITALIZATION. MULTIPLE DEVICES USED DURING LAPAROSCOPIC PROCEDURE. 5/22/97 ADD'L INFO RECEIVED FROM SALES REP AFTER FOLLOW UP WITH THE SURGEON. THE INJURY WAS A COMMON BILE DUCT INJURY CAUSED DURING THE CHOLANGIOGRAM. NO EES INSTRUMENTS WERE INVOLVED. ALL INSTRUMENTS HAVE BEEN DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH DILATING TIP TROCAR TROCAR GCJ ETHICON ENDO-SURGERY, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 *