BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOPATH OPTIVIEW SURG. OPTICAL OBTURATOR & SLEEVE

    MDR report key: 99193 · Received June 20, 1997

    Report

    Report Number
    1527736-1997-01356
    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
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    05/21/97 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 THEN COMMON DUCT JUNCTIVE WHICH REQUIRED SURGICAL REPAIR. PROLONGED SURGICAL 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. 6/3/97 SURGEON HAD PERFORMED A LAPAROSCOPIC CHOLECYSTECTOMY. IN THE POST OPERATIVE PERIOD THE PT DEVELOPED A BILE LEAK. THE PT REQUIRED AN EXPLORATION BY DR IN N.C.. AT THAT TIME, THERE WAS NOTED TO BE NO CLIPS ON THE CYSTIC DUCT. THERE WAS ALSO A PSEUDOANEURSYM OF THE CYSTIC ARTERY. CO HAS ATTEMPTED TO CONTACT DR. TO OBTAIN MORE INFO. THERE IS NO OTHER MATERIALS FOR CO TO EXAMINE. W.A.B.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH OPTIVIEW SURG. OPTICAL OBTURATOR & SLEEVE TROCAR GCJ ETHICON ENDO-SURGERY, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 *