BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ENDOSCOPIC VASCULAR LINEAR CUTTER

    MDR report key: 84944 · Received April 15, 1997

    Report

    Report Number
    1527736-1997-00516
    Event Type
    Malfunction
    Date Received
    April 15, 1997
    Date of Event
    December 20, 1996
    Report Date
    April 7, 1997
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GAG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS OF EVALUATION: 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. DUE TO THE DAMAGED FIRING MECHANISM THE INSTRUMENT MAY BECOME DIFFICULT TO RELEASE FROM TISSUE. COMMENTS: 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 PRIRO TO COMPLETE CLAMPING OF THE JAWS AND FAILURE TO PROPERLY FOLLOW RELOADING INSTRUCTIONS.

    Description of Event or Problem · 1

    DURING A LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY THE SURGEON ON THE FIRST FIRING OF THE EZ35W COMPLETELY CLOSED THE LOCKING TRIGGER THEN PULLED THE FIRING TRIGGER. A LOUD CRUNCH WAS HEARD. THE LOCKING TRIGGER AND FIRING TRIGGER WERE RELEASED WITH THE THUMB RELEASE BUTTON. NO STAPLES WERE LAID AND THE BLADE DID NOT CUT. THE INSTRUMENT DID NOT FUNCTION PROPERLY AFTER THE CRUNCH. A SECOND EZ35W WAS PULLED WITH THE SAME RESULTS. THE THIRD EZ35W WAS USED TO COMPLETE THE CASE. THERE WS NO CONSEQUENCE TO THE PATIENT. 12/23/1996 1315 LEFT MESSAGE AND 800# FOR M.D. TO CALL BACK. 12/24/1996 NNCL SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ENDOSCOPIC VASCULAR LINEAR CUTTER ENDOSCOPIC LINEAR CUTTER GAG ETHICON ENDO-SURGERY, INC. NA HC5315

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other