BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH THORACIC ENDO LINEAR CUTTER W/SAGETY LOCK

    MDR report key: 82259 · Received February 20, 1997

    Report

    Report Number
    1527736-1997-00065
    Event Type
    Malfunction
    Date Received
    February 20, 1997
    Date of Event
    January 22, 1997
    Report Date
    February 20, 1997
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GAG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    H6; CODE 400: DAMAGED FIRING MECHANISM. BASED UPON THE INFO RECEIVED AND THE VISUAL EXAMINATION, IT WAS CONCLUDED THAT THE INSTRUMENT WAS RETURNED NON-FUNCTIONAL. THE RETURNED CARTRIDGE HAD BROKEN ALIGNMENT FANGS. THE INSTRUMENT WAS DISASSEMBLED AND FOUND TO HAVE A DAMAGED FIRING MECHANSIM. NO CONCLUSION COULD BE REACHED AS TO HOW THIS DAMAGE OCCURRED. SOME CONDITONS WHICH MIGHT RESULT IN DAMAGE TO THE FIRING MECHANISM ARE: INTERRUPTED FIRING CYLCE, 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 IMRPOVE CO'S PRODUCTS.

    Description of Event or Problem · 1

    DURING A THORACOTOMY THE SURGEON WAS INSERTING THE EZ45G INTO THE CHEST WALL AND THE INSTRUMENT WOULD NOT OPEN. THE INSTRUMENT WAS REMOVED AND A SECOND INSTRUMENT WAS OPENED TO COMPLETE CASE. NO CONSEQUENCE TO THE PT. (NO BUTTRESSING MATERIAL WAS USED). 1/27/97 NO ANSWER. 1/27/97 1510 ATTEMPTED TO CONTACT SURGEON BUT NO ANSWER. 1/29/97 1331 NO ANSWER. 1/29/97 1333 CALLED DIRECTORY ASSISTANCE AND OBTAINED CORRECT PHONE NUMBER FOR SURGEON. 1/29/97 1334 MESSAGE AND 800# LEFT FOR MD TO CALL BACK. 1/29/97 1404 SURGEON CALLED BACK AND STATED ON APPROX THE THIRD FIRING, THE INSTRUMENT "WOULD NOT COME APART." IT WAS OPENED BY PRYING JAWS OPEN AND IN THE PROCESS THE HANDLE BROKE. IT DID NOT LAY STAPLES OR CUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH THORACIC ENDO LINEAR CUTTER W/SAGETY LOCK ENDOSCOPIC LINEAR CUTTER GAG ETHICON ENDO-SURGERY, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other