BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIGASURE V SEALER/DIVIDER

    MDR report key: 4859233 · Received June 22, 2015

    Report

    Report Number
    3006451981-2015-00145
    Event Type
    Death
    Date Received
    June 22, 2015
    Date of Event
    April 15, 2015
    Report Date
    June 17, 2015
    Manufacturer
    COVIDIEN MEDICAL PRODUCTS (SHANGHAI) MAN
    Product Code
    GEI
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF FOLLOW-UP REPORT : (B)(6) 2015. ONE USED LS1500 WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION FOUND THAT THE TIP OF THE MOVING JAW HAD DISENGAGED. THE MOVING JAW HAD BROKE AND DISENGAGED HELD ONLY BY THE GRAY WIRE. THE CENTER PLASTIC BRIDGE WAS MISSING. THE INSTRUMENT HAD DRIED BLOOD IN AND AROUND THE JAWS. FURTHER INVESTIGATION FOUND THAT THE USER MOST LIKELY EXERTED A SIGNIFICANT AMOUNT OF FORCE TO THE TIP OF THE JAWS WHILE CLAMPED ON A HARD AND LARGER THEN RECOMMENDED OBJECT. SUCH FORCE ON THE TIP OF THE JAWS COULD CRACK THE A MODEL AND SEPARATE IT FROM THE JAW. THE INVESTIGATION IDENTIFIED THE ROOT CAUSE OF THE DAMAGED DEVICE TO BE ATTRIBUTED TO USER HANDLING. MARKINGS ON THE JAWS INDICATE OPTIMAL TISSUE PLACEMENT. GRASP THE INTENDED VESSEL AND/OR TISSUE IN THE CENTER OF THE JAWS. THE IFU STATES, AVOID GRASPING OBJECTS, SUCH AS STAPLES, CLIPS OR ENCAPSULATED SUTURES, IN THE JAWS OF THE INSTRUMENT. NO TREND HAS BEEN IDENTIFIED FOR THIS FAILURE MODE. NO CORRECTIVE ACTION IS REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE INCIDENT SAMPLE HAS BEEN REQUESTED BUT TO DATE HAS NOT BEEN RECEIVED FOR EVALUATION. IF THE SAMPLE IS RECEIVED OR IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: DEVICE RECEIVED FOR INVESTIGATION AND IT WAS NOTED THAT THERE WAS A MISSING PLASTIC A MODEL BRIDGE FROM JAW, IN ADDITION TO THE TIP OF THE JAW AND SEAL PLATE BEING BROKEN.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A TAMIS TME.PROCEDURE THERE WERE ISSUES WITH 2 LS1500 DEVICES. FOR THE FIRST LIGASURE LS1500, THERE WERE PROBLEMS WITH THE JAW BREAKING DURING USE, SO IT WAS REPLACED.. FOR THE SECOND LS 1500, SEALING/CUTTING WAS NOT POSSIBLE AS THE DEVICE DID NOT ACTIVATE.. THERE WAS NO EXTENSION OF OPERATING TIME, NO BLOOD LOSS, NO EXTENSION OF INCISION, NO CHANGE OF OPERATION, NO LOSS OR DAMAGE TO TISSUE.THE PATIENT DIED TWO DAYS AFTER SURGERY ON (B)(6) 2015. ALL OF THE INVOLVED PERSONS UNDERLINE THAT THIS IS NOT THE RESULT OF THE PROBLEMS WITH THE INSTRUMENTS LIGASURE. PRE-EXISTING CONDITIONS, COURSE OF TREATMENT AND CAUSE OF DEATH ARE UNKNOWN. SITE WILL NOT BE PROVIDING ANY ADDITIONAL DETAILS. COVIDIEN SALES REPRESENTATIVE NOTIFIED OF EVENT ON (B)(6)2015.LATE NOTIFICATION TO SALES REPRESENTATIVE DUE TO SITE NOT RELEASING INFORMATION UNTIL INTERNAL REVIEW WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403781 LIGASURE V SEALER/DIVIDER LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN MEDICAL PRODUCTS (SHANGHAI) MAN LS1500 S5AB023X

    Patients

    Seq Age Sex Outcome Treatment
    1 Death