BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH THORACIC LINEAR CUTTER WITH S

    MDR report key: 45960 · Received September 18, 1996

    Report

    Report Number
    1527736-1996-00142
    Event Type
    Malfunction
    Date Received
    September 18, 1996
    Date of Event
    August 15, 1996
    Report Date
    September 18, 1996
    Manufacturer
    ETHICON ENDO-SURGERY,INC.
    Product Code
    GAG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY INADVERTENTLY LEFT OFF OF FOLLOW UP REPORT #1. RESULTS OF EVALUATION: CONCLUSION: BASED UPON THE INQUIRY INFO RECEIVED, THE VISUAL EXAMINATION, AND THE FUNCTIONAL TESTING, NO CONCLUSION COULD BE REACHED AS TO WHY THE INSTRUMENT REPORTEDLY "DROPPED THE CARTRIDGE" DURING SURGERY. THE INSTRUMENT WAS RETURNED WITH A NICKED KNIFE, BUT WAS OTHERWISE IN GOOD PHYSICAL CONDITION. NO CONCLUSION COULD BE REACHED AS TO HOW THE KNIFE HAD BECOME DAMAGED. THE CARTRIDGE RETENTION FEATURE WAS MEASURED AND WAS FOUND TO BE CONFORMING. THE INSTRUMENT WAS CYCLED, FIRED, AND FORMED THE STAPLES WITHIN DESIGN SPECIFICATION BUT HAD A ROUGH CUT DUE TO THE NICKED KNIFE. THE INSTRUMENT WAS DISASSEMBLED TO EXAMINE THE INTERNAL COMPONENTS AND NO DEFORMATIONS COULD BE ID. IT WAS CONCLUDED THAT THE INSTRUMENT WAS FULLY FUNCTIONAL AND CONFORMING TO DESIGN SPECIFICATIONS. THE EXPERIENCE THE SURGEON REPORTED COULD NOT BE REPEATED. EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE IT FUNCTIONS PROPERLY.

    Description of Event or Problem · 1

    THE DEVICE WAS USED DURING A V.A.T.S. PROCEDURE. ON THE SECOND FIRING, THE CARTRIDGE DID NOT FIT THE INSTRUMENT AND FELL INTO THE PT (COULD RECOVER FROM THE PT.) AFTER THAT THE DR. FIRED TWICE WITH THE SAME INSTRUMENT AND FELT HARD FEEDBACK TO FIRE. THE INSTRUMENT COULD NOT ROTATE. THERE WAS NO CONSEQUENCE TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH THORACIC LINEAR CUTTER WITH S ENDOSCOPIC LINEAR CUTTER GAG ETHICON ENDO-SURGERY,INC. NA J43210

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention