BEUDAMED
    FDA Adverse Event Summary report: N

    LIGASURE V SEALER/DIVIDER

    MDR report key: 4143362 · Received October 6, 2014

    Report

    Report Number
    1717344-2014-00693
    Date Received
    October 6, 2014
    Date of Event
    July 7, 2014
    Report Date
    July 10, 2014
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INCIDENT DEVICE HAS BEEN RECEIVED AND IS UNDER EVALUATION. WHEN THE DEVICE EVALUATION IS COMPLETE A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). ONE USED LS1500 WAS RECEIVED FOR EVALUATION, RATHER THAN THE REPORTED LF1537. THE DEVICE WAS RETURNED IN A LF1537 DISPLAY BOX. INITIAL VISUAL INSPECTION FOUND NO DEFECTS WITH THE DEVICE. THE DEVICE WAS ACTIVATED ON SIMULATED TISSUE AND THE HAND-SWITCH DID NOT FUNCTION. UPON INTERNAL INSPECTION, THE INVESTIGATION NOTED THERE WAS A CRACKED SOLDER ON THE SWITCH LEGS. WHEN THE DEVICE WAS TESTED WITH A FOOTSWITCH IT ACTIVATED SATISFACTORILY. FUNCTIONAL TESTING WAS PERFORMED ON PORCINE KIDNEY TISSUE USING THE FOOTSWITCH ONLY. MULTIPLE SEALS ON VARIOUS SIZE VESSELS WERE MADE. ALL SEAL CYCLES WERE COMPLETED SATISFACTORILY AND END TONES WERE HEARD INDICATING COMPLETED ACTIVATION CYCLES. THE INVESTIGATION FOUND THAT THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE CONFIRMED. HOWEVER AN UNRELATED FAILURE WAS IDENTIFIED TO BE TO BE POOR SOLDER FLOW ON THE PCB SWITCH LEGS ATTRIBUTED TO THE CABLE SUPPLIER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE COULD NOT SEAL THE VESSEL DURING AN APPENDECTOMY. END TONES, INDICATING A COMPLETED SEAL CYCLE, WERE HEARD. COLON TISSUE AND VESSELS WERE BEING SEALED. THERE WAS NO BLEEDING. A NEW LIGASURE WAS OPENED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622618 LIGASURE V SEALER/DIVIDER LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP 40310149X

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR