BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH THORACIC ENDO LINEAR CUTTER W/SAFETY LOCK

    MDR report key: 112747 · Received August 12, 1997

    Report

    Report Number
    1527736-1997-01945
    Event Type
    Malfunction
    Date Received
    August 12, 1997
    Date of Event
    July 15, 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

    FACILITY EXPERIENCED AN EVENT WITH ENDOPATH* THORACIC ENDOSCOPIC LINEAR CUTTER WITH SAFETY LOCK ON 7/15/97 WHILE PERFORMING A THORACOSCOPY. THE PRODUCT COMPLAINT ANALYSIS TEAM HAS COMPLETED ITS INVESTIGATION OF THE DEVICE WHICH WAS RETURNED TO CO WITH PRODUCT INQUIRY # 974330. THE RESULTS OF THE INVESTIGATION CONDUCTED BY THE APPROPRIATE ENGINEERS AND TECHNICIANS ARE LISTED BELOW. VISUAL INSPECTIONS & RESULTS: LOCKOUT POSITION, AD UNFIRED BC FIRED; CARTRIDGE CONDTION, A PART BC FULLY FIRED; CARTRIDGE RETURN BATCH NUMBER, ABC K00U9W D K. 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 INQUIRY INFO RECEIVED, THE VISUAL EXAMINATION, AND THE FUNCTIONAL TESTING, NO CONCLUSION COULD BE REACHED AS TO WHY THE INSTRUMENT REPORTEDLY "WOULD NOT 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 DEFORMATIONS 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. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT OCCURS IN ORDER TO CONTINUOUSLY IMPROVE CO'S PRODUCTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THE EZ45B WAS USED DURING A THORACOSCOPY WITH WEDGE RESECTION. ON THE FIRST FIRING THE SURGEON ACCIDENTLY FIRED THE BLACK TRIGGER WITH THE WHITE HANDLE CLOSED BEFORE PLACING THE DEVICE ON THE TISSUE. THE FIRING STROKE WAS NOT COMPLETED AND THE CARTRIDGE WAS DISCARDED. ON THE SECOND FIRING THE SURGEON HAD TROUBLE CLOSING THE DEVICE AND IT DID NOT APPEAR AS TOO MUCH TISSUE WAS IN THE JAWS. THE DEVICE WAS CLOSED AND FIRED. AFTER FINAL FIRING IT WAS NOTICED THERE WERE UNFORMED STAPLES LYING IN THE STAPLE LINE. THE REP IS RETURNING THREE RELOADS (BLUE CARTRIDGE WAS NOT USED) WITH THE DEVICE. THERE WAS NO CONSEQUENCE TO THE PATIENT. 07/15/97 IT WAS REPORTED THE FIRST FIRING OF THE DEVICE WAS OUTSIDE THE BODY. THE SECOND FIRING WAS FINE...ON THE THIRD FIRING THERE WAS DIFFICULTY CLOSING THE DEVICE BUT IT FIRED FINE. ON THE FOURTH FIRING THERE WAS LESS DIFFICULTY CLOSING THE DEVICE. THE STAPLE LINE LOOKED COMPLETE, BUT THERE WERE 3 OR 4 UNFORMED STAPLES LYING ON THE STAPLE LINE. THE CASE WAS COMPLETED WITH THE DEVICE. THE REP IS RETURNING THE DEVICE AND (3) ZR45GS AND (1) ZR45B WHICH WAS NOT FIRED.

    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 K4694G

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other