BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH TRISTAR EXTRAPERITONEAL DISSECTOR

    MDR report key: 90363 · Received May 8, 1997

    Report

    Report Number
    1527736-1997-00891
    Event Type
    Malfunction
    Date Received
    May 8, 1997
    Date of Event
    April 7, 1997
    Report Date
    May 8, 1997
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    H6; CODE 100: BALLOON TORN. FACILITY EXPERIENCED AN EVENT WITH THE ENDOPATH TRISTAR EXTRAPERITONEAL DISSECTOR WHILE PERFORMING A LAP HERNIA REPAIR. THE PRODUCT COMPLAINT ANALYSIS TEAM HAS COMPLETED ITS INVESTIGATION OF THE DEVICE WHICH WAS RETURNED TO CO WITH PRODUCT INQUIRY #972264. THE RESULTS OF THE INVESTIGATION CONDUCTED BY THE APPROPRIATE ENGINEERS AND TECHNICIANS ARE LISTED BELOW. VISUAL INSPECTIONS & RESULTS: BALLOON CONDITION, TORN; STOPCOCK CONDITION, GOOD/PARTIALLY OPEN; CAM CONDITION, DESUFFLATION LEVER CONDITION, EXTENSION CONDITION, INNER GASKET CONDITION, OUTER GASKET CONDITION, AND SLEEVE CONDITION, GOOD. FUNCTIONAL TESTS & RESULTS: BALLOON INFLATION TEST, COULD NOT INSUFFLATE. ANALYSIS CONCLUSION: BASED UPON THE INQUIRY INFO RECEIVED AND THE VISUAL EXAMINATION, IT WAS CONCLUDED THAT THE BALLOON HAD TORN, AND IT APPEARED THAT ALL THE PIECES WERE RETURNED, MAKING THE INSTRUMENT NON FUNCTIONAL. THE DEVICE WAS RECEIVED WITH THE BALLOON TORN AROUND THE DISTAL END APPROX. 1/4" FROM THE TIP. THE TEAR WAS ALMOST 360 DEGREES IN CIRCUMFERENCE. NO CONCLUSION COULD BE REACHED AS TO HOW THE BALLOON HAD BECOME TORN. EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE THAT IT FUNCTIONS PROPERLY. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT OCCURS IN ORDER TO CONTINUOUSLY IMPROVE THE PRODUCTS.

    Description of Event or Problem · 1

    THE DEVICE WAS USED DURING A LAPAROSCOPIC HERNIA REPAIR, IT WAS REPORTED THE SURGEON SAID THE BALLOON BURST AFTER 2 PUMPS AFTER INSERTING IT IN THE PRE-PERITONEAL SPACE. THE SURGEON USED AN ORIGIN BALLOON DISSECTOR TO COMPLETE THE PROCEDURE. THERE WAS NO CONSEQUENCE TO THE PT. 04/18/97 1000 SURGEON CALLED BACK AND CONFIRMED THE INFORMATION AS REPORTED BY THE REP. SURGEON STATED HE DID A LARGE CUT DOWN BEFORE INSERTING THE INSTRUMENT. HE DID NOT USE FORCE TO INSERT THE INSTRUMENT, NOR DID HE USE S-RETRACTORS OR LUBRICANTS. SUTURE WAS USED TO RETRACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH TRISTAR EXTRAPERITONEAL DISSECTOR DISSECTOR GCJ ETHICON ENDO-SURGERY, INC. NA J00D0K

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other