BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH TRISTAR EXTRAPERITONEAL DISSECTOR

    MDR report key: 114269 · Received August 19, 1997

    Report

    Report Number
    1527736-1997-02022
    Event Type
    Malfunction
    Date Received
    August 19, 1997
    Report Date
    June 26, 1997
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GCJ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT COMPLAINT ANALYSIS TEAM HAS COMPLETED ITS INVESTIGATION OF THE DEVICE WHICH WAS RETURNED TO CO WITH PRODUCT INQUIRY #974894. THE RESULTS OF THE INVESTIGATION CONDUCTED BY THE APPROPRIATE ENGINEERS AND TECHNICIANS ARE LISTED BELOW. VISUAL INSPECTIONS & RESULTS: BALLOON CONDITION, BURST; CAM CONDITION, DESUFFLATION LEVER CONDITION, EXTENSION CONDITION, INNER GASKET CONDITION, OUTER GASKET CONDITION, AND SLEEVE CONDITION, GOOD; AND STOPCOCK CONDITION, GOOD/CLOSED. 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 BURST, MAKING THE INSTRUMENT NON FUNCTIONAL. THE INSTRUMENT WAS RECEIVED WITH A BALLOON WHICH HAD BURST AND 25% OF THE BALLOON WAS STILL ATTACHED. THE BALLOON WAS RE-EVALUATED AND PIECED TOGETHER PIECE BY PIECE AND IT WAS CONCLUDED THAT 100% OF THE BALLOON WAS RETURNED WITH THE PRODUCT. THE POINT OF PROPAGATION COULD NOT BE DETERMINED. NO CONCLUSION COULD BE REACHED WHY THE BALLOON BURST. EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE THAT IT FUNCTIONS PROPERLY. THE MFG PROCESS HAS BEEN MODIFIED AND THE BALLOON'S MATERIAL HAS ALSO BEEN MODIFIED TO REDUCE THE OCCURRENCE OF THIS INCIDENT. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT OCCURS IN ORDER TO CONTINUOUSLY IMPROVE CO'S PRODUCTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE WAS USED DURING AN UNKNOWN PROCEDURE. IT WAS REPORTED BY THE AFFILIATE THAT THE BALLOON BURST. THERE WAS NO PATIENT CONSEQUENCE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN