BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH THORACIC ENDO LINEAR CUTTER W/SAFETY LOCK

    MDR report key: 98245 · Received June 12, 1997

    Report

    Report Number
    1527736-1997-01290
    Event Type
    Malfunction
    Date Received
    June 12, 1997
    Date of Event
    May 2, 1997
    Report Date
    June 11, 1997
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GAG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT ANALYSIS TEAM HAS COMPLETED ITS INVESTIGATION OF DEVICE WHICH WAS RETURNED TO CO WITH PRODUCT INQUIRY #973557. VISUAL INSPECTIONS & RESULTS: LOCKOUT POSITION, UNFIRED; CARTRIDGE CONDITION, PARTIALLY FIRED; CARTRIDGE RETURN BATCH NUMBER, J00A50 AND CONDITION OF KNIFE, GOOD. FUNCTIONAL TESTS & RESULTS: CONDITION OF FIRING TRIGGER LOCKOUT, GOOD; CONDITION OF PINION GEAR, GOOD; CONDITION OF SHORT RACK, GOOD AND CONDITION OF YOKE, GOOD. ANALYSIS CONCLUSION: BASED UPON INQUIRY INFO RECEIVED, VISUAL EXAMINATION AND FUNCTIONAL TESTING, NO CONCLUSION COULD BE REACHED AS TO WHY INSTRUMENT REPORTEDLY "DROPPED THE CARTRIDGE" DURING SURGERY. INSTRUMENT WAS RETURNED IN GOOD PHYSICAL CONDITION. CARTRIDGE RETENTION FEATURE WAS MEASURED AND WAS FOUND TO BE WITHIN DESIGN SPECIFICATION. INSTRUMENT WAS CYCLED, FIRED, CUT, AND FORMED STAPLES WITHIN DESIGN SPECIFICATION. INSTRUMENT WAS DISASSEMBLED TO EXAMINE INTERNAL COMPONENTS AND NO DEFORMATIONS COULD BE IDENTIFIED. IT WAS CONCLUDED THAT INSTRUMENT WAS FULLY FUNCTIONAL AND CONFORMING TO DESIGN SPECIFICATIONS. EXPERIENCE 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

    THE DEVICE WAS USED DURING A V.A.T.S. PROCEDURE. THE CARTRIDGE FELL INTO THE PT. THE CARTRIDGE WAS RETRIEVED. 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 J42U0N

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other