BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE

    MDR report key: 7810113 · Received August 23, 2018

    Report

    Report Number
    3006451981-2018-00574
    Event Type
    Malfunction
    Date Received
    August 23, 2018
    Date of Event
    June 27, 2018
    Report Date
    October 29, 2018
    Manufacturer
    COVIDIEN MEDICAL PRODUCTS
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    EVALUATION SUMMARY: ONE DEVICE WAS RECEIVED FOR EVALUATION. THE RETURNED PRODUCT MET SPECIFICATION AS RECEIVED. VISUAL INSPECTION FOUND NO DEFECTS. THE REPORTED CONDITION WAS NOT CONFIRMED. FUNCTIONAL TESTING WAS PERFORMED WITH THE RETURNED DEVICE ON PORCINE KIDNEY TISSUE. MULTIPLE SEALS ON VARIOUS SIZE VESSELS WERE MADE WITH VISUALLY ACCEPTABLE RESULTS. ALL SEAL CYCLES WERE COMPLETED SATISFACTORILY AND END TONES WERE HEARD INDICATING COMPLETED ACTIVATION CYCLES. THE KNIFE CUT OF THE DEVICE WAS TESTED ON A SILICONE TEST STRIP WITH ACCEPTABLE RESULTS. THE BLADE MOVED SMOOTHLY ALONG THE KNIFE TRACK AND RETURNED TO THE HOME POSITION WHEN THE TRIGGER WAS RELEASED. THE INVESTIGATION FOUND THE DEVICE TO FUNCTION NORMALLY AND WITHIN SPECIFICATIONS. REFER TO THE PRODUCT INSTRUCTIONS FOR USE FOR RECOMMENDATIONS ON TISSUE SEALING. THE INSTRUCTIONS FOR USE (IFU) STATES, KEEP THE INSTRUMENT JAWS CLEAN. BUILD-UP OF ESCHAR MAY REDUCE THE SEAL AND / OR CUTTING EFFECTIVENESS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS NOT SOLD IN US AND IS 510(K) EXEMPT. THIS REPORT IS ASSOCIATED TO A SIMILAR PRODUCT SOLD IN THE US WITH 510(K) NUMBER K102470. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, DURING GENERAL SURGERY, AFTER ACTIVATING THREE TO FOUR TIMES, THE DEVICE DID NOT WORK. IT HAD NOT COAGULATED. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    649176 LIGASURE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI COVIDIEN MEDICAL PRODUCTS LF1212 S6DH716X

    Patients

    Seq Age Sex Outcome Treatment
    1