BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE

    MDR report key: 6721686 · Received July 18, 2017

    Report

    Report Number
    3006451981-2017-05442
    Event Type
    Malfunction
    Date Received
    July 18, 2017
    Date of Event
    June 26, 2017
    Report Date
    June 26, 2017
    Manufacturer
    COVIDIEN MEDICAL PRODUCTS
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: ONE USED LF1212 LIGASURE DEVICE WAS RECEIVED, AND EVALUATION OF THE RETURNED SAMPLE COULD NOT CONFIRM THE REPORTED ISSUE. VISUAL INSPECTION FOUND NO DEFECTS. THE DEVICE WAS ACTIVATED MULTIPLE TIMES ON PORCINE KIDNEY SAMPLES, PRESSING THE BUTTON IN VARIOUS LOCATIONS ON A RANGE OF VESSEL SIZES TO DETECT ANY ACTIVATION ISSUES. ALL SEAL CYCLES WERE COMPLETED SATISFACTORILY, AND A VISUAL SEAL EFFECT WITH AN END TONE WAS OBSERVED FOR EACH APPLICATION. THE INVESTIGATION FOUND THE DEVICE TO FUNCTION NORMALLY AND WITHIN SPECIFICATIONS. THERE ARE FACTORS DURING USE THAT CAN AFFECT SEAL QUALITY, AND THE INSTRUCTIONS FOR USE INCLUDED WITH THIS PRODUCT LISTS MEASURES TO ENSURE SEALING EFFECTIVENESS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    DEVICE IS NOT SOLD WITHIN THE U.S., BUT IS SIMILAR TO ANOTHER APPROVED DEVICE: (B)(4), 510K K102470. THE INCIDENT SAMPLE WAS REQUESTED BUT TO DATE HAS NOT BEEN RECEIVED FOR EVALUATION. IF THE SAMPLE OR ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A HEAD AND NECK PROCEDURE, THE DEVICE DID NOT SEEM TO SEAL WELL AND HAD NO THERMAL SPREAD. NO PATIENT INJURY RESULTED OR MEDICAL INTERVENTION WAS REQUIRED. A NEW DEVICE WAS USED TO CONTINUE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    503574 LIGASURE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI COVIDIEN MEDICAL PRODUCTS LF1212 S7BH002X

    Patients

    Seq Age Sex Outcome Treatment
    1