BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH THORACIC ENDO LINEAR CUTTER W/SAFETY LOCK

    MDR report key: 110012 · Received July 31, 1997

    Report

    Report Number
    1527736-1997-01863
    Event Type
    Malfunction
    Date Received
    July 31, 1997
    Report Date
    July 6, 1997
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GAG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    FACILITY EXPERIENCED AN EVENT WITH ENDOPATH* THORACIC ENDOSCOPIC LINEAR CUTTER WITH SAFETY LOCK ON WHILE PERFORMING A THORACOSCOPY. THE PRODUCT COMPLAINT ANALYSIS TEAM HAS COMPLETED ITS INVESTIGATION OF THE DEVICE WHICH WAS RETURNED TO CO WITH PRODUCT INQUIRY #974254. THE RESULTS OF THE INVESTIGATION CONDUCTED BY THE APPROPRIATE ENGINEERS AND TECHNICIANS ARE LISTED BELOW. VISUAL INSPECTIONS & RESULTS: LOCKOUT POSITION, UNFIRED; CARTRIDGE CONDITIONS, UNFIRED; CARTRIDGE RETURN BATCH NUMBER, J00M6X AND INSTRUMENT NUMBER, 98. 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 THE INQUIRY INFO RECEIVED, THE VISUAL EXAMINATION, AND THE FUNCTIONAL TESTING, NO CONCLUSION COULD BE REACHED AS TO WHY THE INSTRUMENT REPORTEDLY "DROPPED THE RELOAD" DURING SURGERY. THE INSTRUMENT WAS RETURNED IN GOOD PHYSICAL CONDITION. THE CARTRIDGE RETENTION FEATURE WAS MEASURED AND WAS FOUND TO BE WITHIN DESIGN SPECIFICATION. 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 EZ45 WAS USED DURING A THORACOSCOPY. IT WAS REPORTED THE SURGEON INSERTED THE EZ45 INTO A MINITHORACOTOMY. THE JAWS WERE OPENED AND THE RELOAD FELL INTO PATIENT. THE RELOAD WAS RETRIEVED AND INSTRUMENT DISCARDED. ANOTHER EZ45 WAS OPENED AND WORKED FINE. THERE WAS NO CONSEQUENCE TO THE PATIENT.

    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 J45L8E

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other