BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH THORACIC LINEAR CUTTER W/SAFETY LOCK

    MDR report key: 87570 · Received April 24, 1997

    Report

    Report Number
    1527736-1997-00743
    Event Type
    Malfunction
    Date Received
    April 24, 1997
    Date of Event
    March 24, 1997
    Report Date
    April 23, 1997
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GAG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FACILITY EXPERIENCED AN EVENT WITH YOUR ENDOPATH THORACIC ENDOSCOPIC LINEAR CUTTER WITH SAFETY LOCK WHILE PERFORMING A GASTRECTOMY. THE PRODUCT COMPLAINT ANALYSIS TEAM HAS COMPLETED ITS INVESTIGATION OF THE DEVICE WHICH WAS RETURNED TO US WITH PRODUCT INQUIRY #972042. THE RESULTS OF THE INVESTIGATION CONDUCTED BY THE APPROPRIATE ENGINEERS AND TECHNICIANS ARE LISTED BELOW. VISUAL INSPECTIONS & RESULTS: LOCKOUT POSITION; FIRED. CARTRIDGE CONDITION; 3/4 FIRED. CARTRIDGE RETURN BATCH NUMBER; H00655. CONDITION OF KNIFE; GOOD. INSTRUMENT NUMBER; 0093. FUNCTIONAL TESTS & RESULTS: CONDITION OF FIRING TRIGGER LOCKOUT, CONDITION OF PINION GEAR, CONDITION OF SHORT RACK, AND CONDITION OF YOKE; GOOD. WAS INSTRUMENT CYCLED; 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 INSTRUMENT REPORTEDLY PRODUCED "MALFORMED STAPLES" DURING SURGERY. THE INSTRUMENT WAS RETURNED IN GOOD PHYSICAL CONDITION. THE INSTRUMENT WAS CYCLED, FIRED, CUT, AND FORMED THE STAPLES WITHIN DESIGN SPECIFICATION. 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. 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 GASTRECTOMY PROCEDURE. IT WAS REPORTED BY THE AFFILIATE THAT THE STAPLES WERE MALFORMED.THERE WAS NO PT CONSEQUENCE. ADDITIONAL INFO RECEIVED ON 4/3/97. IT WAS CLARIFIED THAT THE STAPLES WERE MALFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH THORACIC LINEAR CUTTER W/SAFETY LOCK ENDOSCOPIC LINEAR CUTTER GAG ETHICON ENDO-SURGERY, INC. NA J41R5J

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other