BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOPATH TRISTAR EXTRAPERITONEAL DISSECTOR

    MDR report key: 104402 · Received July 10, 1997

    Report

    Report Number
    1527736-1997-01585
    Event Type
    Injury
    Date Received
    July 10, 1997
    Date of Event
    August 2, 1996
    Report Date
    July 9, 1997
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GCJ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE WAS USED DURING A LAPAROSCOPIC HERNIA REPAIR, IT WAS REPORTED THE DEVICE DEVELOPED A SLOW LEAK AROUND THE TROCAR SLEEVE. A SECOND DEVICE WAS OPENED AND RUPTURED AFTER A FEW PUMPS. A THIRD DEVICE WAS OPENED AND WORKED FAIRLY WELL. SURGEON EXPRESSED CONCERN ABOUT THE EVENT AND ELECTED TO CONVERT TO AN OPEN PROCEDURE TO COMPLETE THE CASE. 08/15/96 THE DOCTOR HAD TROUBLE WITH 2 INSTRUMENTS. HE WAS USING THE TED12 INSTRUMENT TO EXPAND THE SPACE FOR PREPERITONEAL HERNIA REPAIR. HE USED TWO 10/12 AND THERE WERE DIFFICULTIES WITH BOTH. THERE WAS NO EXPANSION ON THE FIRST ONE SECONDARY TO A LEAK. FOLLOWING THE USE OF THE SECOND INSTRUMENT THERE WAS SOME IMPROVEMENT. HE THEN PROCEEDED TO USE A REGULAR TROCAR AND THERE WAS LEAKAGE BETWEEN THE STABILITY THREAD AND THE TROCAR SHAFT. DUE TO THE PROBLEM HE HAD WITH THE TED12 AND MAINTAINING PNEUMOPERITONEUM AND EXPOSURE, HE CONVERTED TO AN OPEN PROCEDURE. IT WAS NOT A SPECIFIC INSTRUMENT AT A SPECIFIC TIME WHICH LED HIM TO THIS DECISION. THE TROCAR WAS DISPOSED. THE TED12 HAS BEEN SAVED AND IS BEING RETURNED. 08/21/1996 0945 RISK MANAGER, IS ON VACATION TILL SEPTEMBER 12. WAS TRANSFERRED AND SPOKE TO SAFETY OFFICER, WHO WILL TRY TO GATHER ANY ADDITIONAL DETAILS AND FORWARD THEM TO EES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH TRISTAR EXTRAPERITONEAL DISSECTOR DISSECTOR GCJ ETHICON ENDO-SURGERY, INC. NA J42D44

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention