BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ENDOSCOPIC LINEAR CUTTER

    MDR report key: 104708 · Received July 10, 1997

    Report

    Report Number
    1527736-1997-01608
    Event Type
    Malfunction
    Date Received
    July 10, 1997
    Date of Event
    June 12, 1997
    Report Date
    July 10, 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

    H6; CODE 400: BROKEN FIRING MECHANISM. FACILITY EXPERIENCED AN EVENT WITH ENDOPATH ENDOSCOPIC LINEAR CUTTER ON 6/12/97 WHILE PERFORMING A UNK PROCEDURE. THE PRODUCT COMPLAINT ANALYSIS TEAM HAS COMPLETED ITS INVESTIGATION OF THE DEVICE WHICH WAS RETURNED TO CO WITH PRODUCT INQUIRY # 973864. THE RESULTS OF THE INVESTIGATION CONDUCTED BY THE APPROPRIATE ENGINEERS AND TECHNICIANS ARE LISTED BELOW. VISUAL INSPECTIONS & RESULTS: LOCKOUT POSITION, FIRED; CARTRIDGE CONDITION, 1/2 FIRED; CARTRIDGE RETURN BATCH NUMBER, J00C45 AND INSTRUMENT NUMBER, 196. FUNCTIONAL TESTS & RESULTS: CONDITION OF FIRING TRIGGER LOCKOUT, GOOD; CONDITION OF PINION GEAR, GOOD; CONDITION OF SHORT RACK, BROKEN AND CONDITION OF YOKE, GOOD. ANALYSIS CONCLUSION: BASED UPON THE INFO REC'D 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 CO'S PRODUCTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE WAS USED DURING AN UNK PROCEDURE. IT WAS REPORTED BY THE AFFILIATE THAT THE DEVICE BROKE AFTER THE THIRD FIRING AND COULD NOT BE USED. A NEW DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ENDOSCOPIC LINEAR CUTTER ENDOSCOPIC LINEAR CUTTER GAG ETHICON ENDO-SURGERY, INC. NA J42NOC

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other