BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH THORACIC ENDO LINEAR CUTTER WITH SAFETY LOCK

    MDR report key: 114394 · Received August 20, 1997

    Report

    Report Number
    1527736-1997-02081
    Event Type
    Malfunction
    Date Received
    August 20, 1997
    Date of Event
    July 18, 1997
    Report Date
    July 22, 1997
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GAG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FACILITY EXPERIENCED AN EVENT WITH ENDOPATH THORACIC ENDOSCOPIC LINEAR CUTTER WITH SAFETY LOCK ON 7/18/97 WHILE PERFORMING A THORACOSCOPY. PRODUCT COMPLAINT ANALYSIS TEAM HAS COMPLETED ITS INVESTIGATION OF THE DEVICE WHICH WAS RETURNED TO CO WITH PRODUCT INQUIRY #974572. THE RESULTS OF THE INVESTIGATION CONDUCTED BY THE APPROPRIATE ENGINEERS AND TECHNICIANS ARE LISTED BELOW. VISUAL INSPECTIONS & RESULTS: LOCKOUT POSITION, CARTRIDGE CONDITION, AND CARTRIDGE RETURN BATCH NUMBER, NA; CONDITION OF KNIFE, AB GOOD; AND INSTRUMENT NUMBER, A 203 B 138. FUNCTIONAL TESTS & RESULTS: CONDITION OF FIRING TRIGGER LOCKOUT, CONDITION OF PINION GEAR, CONDITION OF SHORT RACK, AND CONDITION OF YOKE, AB GOOD; AND WAS INSTRUMENT CYCLED, AB YES. ANALYSIS CONCLUSION: BASED UPON THE INQUIRY INFO RECEIVED, THE VISUAL EXAMINATION, AND THE FUNCTIONAL TESTING, NO CONCLUSION COULD BE REACHED AS TO WHY THE INSTRUMENTS REPORTEDLY "CUT ONLY HALF WAY" DURING SURGERY. THE INSTRUMENTS WERE RETURNED IN GOOD PHYSICAL CONDITION. THE INSTRUMENTS WERE CYLCED, FIRED, CUT, AND FORMED THE STAPLES WITHIN DESIGN SPECIFICATION. THE INSTRUMENTS WERE DISASSEMBLED TO EXAMINE THE INTERNAL COMPONENTS AND NO DEFORMATIONS COULD BE ID. IT WAS CONCLUDED THAT THE INSTRUMENTS WERE 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. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT OCCURS IN ORDER TO CONTINUOUSLY IMPROVE THE PRODUCTS.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A THORACOSCOPY WITH BLEB REMOVAL TWO EZ45B STAPLERS WERE FIRED ON TISSUE AND THE STAPLES FORMED BUT BOTH DEVICES CUT ONLY HALF OF THE WAY. THE CASE WAS COMPLETED BY CUTTING THE TISSUE WITH SCISSORS. THE REP STATED HE HAS LOT NUMBERS OFF OF PACKAGING BUT HE IS UNSURE AS TO WHICH LOT NUMBER GOES TO WHICH DEVICE. THE LOT NUMBERS ARE K46C4J AND K46X8V. HE IS SENDING THE PACKAGING BACK WITH THE DEVICES. THERE WAS NO CONSEQUENCE TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH THORACIC ENDO LINEAR CUTTER WITH SAFETY LOCK ENDOSCOPIC LINEAR CUTTER GAG ETHICON ENDO-SURGERY, INC. NA K46C4J

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other