BEUDAMED
    FDA Adverse Event Death Summary report: N

    NEW LIGASURE 5MM

    MDR report key: 4089958 · Received September 9, 2014

    Report

    Report Number
    1717344-2014-00803
    Event Type
    Death
    Date Received
    September 9, 2014
    Date of Event
    June 27, 2014
    Report Date
    August 13, 2014
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RETURN OF THE INCIDENT SAMPLE HAS BEEN REQUESTED. TO DATE IT HAS NOT BEEN REC'D FOR EVALUATION. ADD'L QUESTIONS IN REGARD TO THE INCIDENT HAVE ALSO BEEN ASKED. IF THE SAMPLE IS REC'D OR IF ADD'L INFO PERTINENT TO THE INCIDENT IS OBTAINED A F/U REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4) 2014. ONE USED LF1537 WAS RECEIVED FOR EVALUATION AND VISUAL INSPECTION FOUND THE JAWS WERE STUCK SHUT DUE TO DRIED RESIDUE. IN ADDITION, DRIED RESIDUE PREVENTED THE JAWS FROM FULLY OPENING. THE DEVICE WAS RECEIVED WITH THE JAWS SHUT. THE TRIGGER FELT STICKY AND THE BLADE DID NOT ADVANCE SMOOTHLY DUE TO ESCHAR IN THE KNIFE TRACK. AFTER CLEANING THE BLADE MOVED ALONG THE TRACK SMOOTHLY AND THE BLADE RETRACTED TO HOME POSITION WITHOUT ASSISTANCE WHEN THE LATCH WAS RELEASED. THE CUSTOMER IS ADVISED TO PUSH FORWARD ON THE HANDLE TO RELEASE THE LATCH. THIS WILL OPEN THE JAWS AND THE BLADE WILL RETRACT TO HOME POSITION. THE INVESTIGATION IDENTIFIED THE ROOT CAUSE OF THE REPORTED EVENT TO BE THE USER INFREQUENTLY CLEANING THE JAWS. TO MINIMIZE TISSUE STICKING KEEP THE JAWS OF THE INSTRUMENT CLEAN AT ALL TIMES; CLEAN THE INSTRUMENT MORE OFTEN WHEN WORKING IN A BLOODY FIELD; IF CONSISTENT STICKING IS ENCOUNTERED, REDUCE THE BAR SETTING; DO NOT RE-USE OR REPROCESS THE DEVICE AS THIS CAN DAMAGE THE SURFACE OF THE JAWS AND LEAD TO IMPROPER PERFORMANCE. THE IFU RECOMMENDS CLEANING THE JAWS WITH A PIECE OF WET GAUZE OFTEN TO HELP MINIMIZE TISSUE BUILD UP BETWEEN THE JAWS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A LIGASURE INSTRUMENT JAMMED IN USE WHILE PERFORMING A DISSECTION OF TISSUE. THE INSTRUMENT'S JAWS WOULD NOT OPEN AND THE BLADE WAS STUCK. THE INSTRUMENT WAS EVENTUALLY CUT FREE FROM THE PATIENT'S TISSUE USING ANOTHER DEVICE. THERE WAS MINIMAL HARM TO THE PATIENT. COVIDIEN WAS ADVISED ON (B)(6) 2014 THAT THE PATIENT HAS SINCE PASSED AWAY. ADD'L INFO HAS BEEN REQUESTED OF THE SITE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE SITE: THE SURGEON¿S EVALUATION ON THE CAUSE OF DEATH FOR THE PATIENT WAS OVERWHELMING SEPSIS FROM SMALL BOWEL PERFORATION AFTER LAPAROSCOPIC ADHESIOLYSIS AND ANTERIOR RESECTION NOT RELATED TO THE LIGASURE DEVICE. THE DEVICE MALFUNCTIONED AND WOULD NOT OPEN AFTER COAGULATING TISSUE IN THE MESOCOLON, FATTY TISSUE CONTAINING BLOOD VESSELS GOING TO THE COLON. THE SURGEON HAD TO USE DIATHERMY TO CUT THIS TISSUE OFF THE LIGASURE DEVICE. THIS PROCEDURE OF DISENGAGING FROM TISSUE AND REMOVING OUT OF THE ABDOMEN WAS DONE IN A SAFE MANNER WITHOUT ANY COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    556298 NEW LIGASURE 5MM LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP 32840177X

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death