BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH THORACIC ENDO LINEAR CUTTER W/SAFETY LOCK

    MDR report key: 134392 · Received November 20, 1997

    Report

    Report Number
    1527736-1997-03081
    Event Type
    Malfunction
    Date Received
    November 20, 1997
    Date of Event
    October 23, 1997
    Report Date
    October 23, 1997
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GAG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    D5,6; H2,3,4,6; G4: ADDED ADDITION INFO. D6: DEVICE RETURNED WITH NO LOT IDENTIFICATION. THE PRODUCT COMPLAINT ANALYSIS TEAM HAS COMPLETED ITS INVESTIGATION OF THE DEVICE. THE RESULTS OF THE INVESTIGATION CONDUCTED BY THE APPROPRIATE ENGINEERS AND TECHNICIANS ARE LISTED BELOW: VISUAL INSPECTIONS & RESULTS: LOCKOUT POSITION, ABCD FIRED; CARTRIDGE CONDITION, ABCD FULLY FIRED AND CARTRIDGE RETURN BATCH NUMBER, ABC K01008 D K0. FUNCTIONAL TESTS & RESULTS: CONDITION OF FIRING TRIGGER LOCKOUT, GOOD; CONDITION OF PINION GEAR, GOOD; CONDITION OF SHORT RACK, GOOD; CONDITION OF YOKE, GOOD; AND WAS INSTRUMENT CYCLED, YES. ANALYSIS CONCLUSION: BASED UPON INQUIRY INFO RECIEVED, THE VISUAL EXAMINATION, AND THE FUNCTIONAL TESTING, NO CONCLUSION COULD BE REACHED AS TO WHY THE INSTRUMENT REPORTEDLY "CUT IMPROPERLY" DURING SURGERY. THE INSTRUMENT WAS RETURNED IN GOOD PHSYICAL CONDITION. THE INSTRUMENT WAS CYLCED, FIED, CUT, AND FORMED THE STAPLES WITHIN DESIGN SPECIFICATION. THE INSTRUMENT WAS DISASSEMBLED TO EXAMINE THE INTERNAL COMPONENTS AND NO DEFORMATIONS COULD BE IDENTIFIED. IT WAS CONCLUDED THAT THE INSTRUMENT WAS FULLY FUNCITONAL AND CONFORMING TO DESIGN SPECIFICATIONS. THE EXPERIENCE THE SURGEON REPORTED COULD NOT BE REPEATED. THE RETURNED PHOTO'S SHOWED AN INCOMPLETE CUT LINE. NO CONCLUSION COULD BE REACHED AS TO WHY THERE WAS AN INCOMPLETE CUT LINE. EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE IT FUNCTIONS PROPERLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THE EZ45G WAS USED ON A THORACOTOMY. IT WAS REPORTED ON THE FIRST FIRING THE DEVICE CUT AND THEN SKIPPED AREA AND THEN CUT AGAIN. THE SURGEON FIRED SCISSORS AND CAUTERY TO COMPLETE THE CUT LINE. THE REP IS RETURNING THE PICTURE OF THE CUT LINE. THERE WAS NO CONSEQUENCE TO THE PT.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other