BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE

    MDR report key: 7135737 · Received December 20, 2017

    Report

    Report Number
    3006451981-2017-05893
    Event Type
    Malfunction
    Date Received
    December 20, 2017
    Date of Event
    December 4, 2017
    Report Date
    March 13, 2018
    Manufacturer
    COVIDIEN MEDICAL PRODUCTS
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: ONE DEVICE SAMPLE WAS RECEIVED FOR EVALUATION. THIS DEVICE HAD BEEN USED IN THE TREATMENT OR DIAGNOSIS OF A PATIENT. WITHOUT THE ORIGINAL PACKAGING OR A REPORTED LOT NUMBER, THE INVESTIGATOR CANNOT DETERMINE IF THE PRODUCT WAS WITHIN THE ASSIGNED EXPIRATION DATE AT THE TIME OF REPORTED INCIDENT. THE RETURNED PRODUCT MET SPECIFICATION AS RECEIVED. VISUAL INSPECTION FOUND NO DEFECTS. VISUAL INSPECTION FOUND NO DEFECTS WITH THE DEVICE. THE DEVICE WAS PLUGGED INTO A GENERATOR AND WAS RECOGNIZED. 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 INVESTIGATION FOUND THE DEVICE TO FUNCTION NORMALLY AND WITHIN SPECIFICATIONS. REFER TO THE PRODUCT INSTRUCTIONS FOR USE FOR RECOMMENDATIONS ON TISSUE SEALING. THE 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

    LF1212 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, AFTER A FEW SEALS THE SURGEON HAD THE FEELING THAT THE SEALING OF THE INSTRUMENT WAS LESS. THERE WASN'T A REGRASP ALARM AND AN END TONE WAS HEARD BUT THERE WAS NO EVIDENCE OF ANY ENERGY DELIVERY. THEY DECIDED TO OPEN A NEW LF1212 AND IT WORKED WELL. THERE WAS NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    915452 LIGASURE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI COVIDIEN MEDICAL PRODUCTS LF1212

    Patients

    Seq Age Sex Outcome Treatment
    1