BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH THORACIC ENDO LINEAR CUTTER W/SAFETYLOCK

    MDR report key: 81275 · Received April 2, 1997

    Report

    Report Number
    1527736-1997-00453
    Event Type
    Malfunction
    Date Received
    April 2, 1997
    Date of Event
    January 24, 1997
    Report Date
    April 2, 1997
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GAG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    H6; CODE 400: DAMAGED FIRING MECHANISM. FACILITY EXPERIENCED AN EVENT WITH YOUR ENDOPATH THORACIC ENDOSCOPIC LINEAR CUTTER WITH SAFETY LOCK WHILE PERFORMING A UNK. THE PRODUCT COMPLAINT ANALYSIS TEAM HAS COMPLETED ITS INVESTIGATION OF THE DEVICE WHICH WAS RETURNED TO CO WITH PRODUCT INQUIRY #971376. THE RESULTS OF THE INVESTIGATION CONDUCTED BY THE APPROPRIATE ENGINEERS AND TECHNICIANS ARE LISTED BELOW. VISUAL INSPECTIONS & RESULTS: LOCKOUT POSITION, AND CARTRIDGE CONDITION; UNFIRED. CARTRIDGE RETURN BATCH NUMBER; J0079F. INSTRUMENT NUMBER; 219. FUNCTIONAL TESTS & RESULTS: CONDITION OF FIRING TRIGGER LOCKOUT, CONDITION OF PINION GEAR, CONDITION OF SHORT RACK, AND CONDITION OF YOKE; GOOD. TEST CARTRIDGE BATCH #; NA. WAS INSTRUMENT CYCLED; NO. ANALYSIS CONCLUSION: BASED UPON THE INFO RECEIVED AND THE VISUAL EXAMINATION, IT WAS CONCLUDED THAT THE INSTRUMENT WAS RETURNED NON-FUNCTIONAL. THE INSTRUMENT WAS DISASSEMBLED AND FOUND TO HAVE A DAMAGED FIRING MECHANISM. NO CONCLUSION COULD BE REACHED AS TO HOW THIS DAMAGE OCCURRED. SOME CONDITIONS WHICH MIGHT RESULT IN DAMAGE TO THE FIRING MECHANISM ARE: INTERRUPTED FIRING CYCLE, TISSUE THICKER THAN INDICATED, ATTEMPTING TO FIRE THROUGH A SPENT CARTRIDGE, FIRING PRIOR TO COMPLETE CLAMPING OF THE JAWS AND FAILURE TO PROPERLY FOLLOW RELOADING INSTRUCTIONS. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT OCCURS IN ORDER TO CONTINUOUSLY IMPROVE THE PRODUCTS.

    Description of Event or Problem · 1

    DURING AN UNKNOWN PROCEDURE, IT WAS REPORTED THE INSTRUMENT WOULD NOT FIRE. NO OTHER DETAILS ARE AVAILABLE. 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/SAFETYLOCK ENDOSCOPIC LINEAR CUTTER GAG ETHICON ENDO-SURGERY, INC. NA J42E20

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other