BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH THORACIC ENDO LINEAR CUTTER W/SAFETY LOCK

    MDR report key: 142044 · Received January 7, 1998

    Report

    Report Number
    1527736-1998-00012
    Event Type
    Malfunction
    Date Received
    January 7, 1998
    Date of Event
    October 1, 1997
    Report Date
    December 9, 1997
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GAG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT COMPLAINT ANALYSIS TEAM HAS COMPLETED ITS INVESTIGATION OF THE DEVICE WHICH WAS RETURNED. THE RESULTS OF THE INVESTIGATION CONDUCTED BY THE APPROPRIATE ENGINEERS AND TECHNICIANS ARE LISTED BELOW. VISUAL INSPECTIONS & RESULTS: LOCKOUT POSITION, UNFIRED; CARTRIDGE CONDITION, PARTIALLY FIRED AND CARTRIDGE RETURN BATCH NUMBER, K00Z3U. FUNCTIONAL TESTS & RESULTS: CONDITION OF FIRING TRIGGER LOCKOUT, GOOD; CONDITION OF PINION GEAR, GOOD; CONDITION OF SHORT RACK, GOOD; CONDITION OF YOKE, GOOD AND TEST CARTRIDGE BATCH #, K01142. ANALYSIS CONCLUSION: BASED UPON THE INFO RECEIVED, THE VISUAL EXAMINATION, AND THE FUNCTIONAL TESTING, NO CONCLUSION COULD BE REACHED AS TO WHY THE INSTRUMENT REPORTEDLY "WOULD NOT OPEN OR CLOSE" DURING SURGERY. THE INSTRUMENT WAS RETURNED IN GOOD PHYSICAL CONDITION. THE INSTRUMENT WAS CYCLED, FIRED, CUT AND FORMED THE STAPLES WITHIN DESIGN SPECIFICATION. THE INSTRUMENT WAS DISASSEMBLED TO EXAMINE THE INTERNAL COMPONENTS AND NO DEFORMITIES COULD BE IDENTIFIED. 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

    IT WAS REPORTED THE DEVICE WAS USED DURING A THORACIC PROCEDURE. IT WAS REPORTED BY THE AFFILIATE THAT THE CUSTOMER REPORTS THAT THE STAPLER DID OPEN AND CLOSE, BUT THEN SOMETHING HAPPENED AND THE SPRINGS WOULD NOT OPEN THE JAWS AGAIN. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH THORACIC ENDO LINEAR CUTTER W/SAFETY LOCK ENDOSCOPIC LINEAR CUTTER GAG ETHICON ENDO-SURGERY, INC. NA K47C10

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other