BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARYLAND JAW OPEN (23CM)

    MDR report key: 4821361 · Received June 5, 2015

    Report

    Report Number
    1717344-2015-00391
    Event Type
    Malfunction
    Date Received
    June 5, 2015
    Date of Event
    April 30, 2015
    Report Date
    May 7, 2015
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    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

    COVIDIEN REFERENCE #: (B)(4). THIS REPORT IS BASED ON INFORMATION PROVIDED BY POST MARKET VIGILANCE INVESTIGATION PERSONNEL. ONE USED LF1723 WAS RECEIVED FOR EVALUATION. THE RETURNED SAMPLE MET SPECIFICATION AS RECEIVED. A REVIEW OF THE LOT NUMBER REPORTED INDICATES THAT THE PRODUCT WAS WITHIN THE ASSIGNED EXPIRATION DATE AT THE TIME OF REPORTED INCIDENT. VISUAL INSPECTION FOUND NO DEFECTS. THE REPORTED CONDITION WAS NOT CONFIRMED. THE DEVICE WAS MECHANICALLY TESTED AND THE LEVER, TRIGGER, ROTATION WHEEL, JAWS, AND KNIFE FUNCTIONED PROPERLY. THE JAW FORCE WAS ACCEPTABLE. THE DEVICE WAS PLUGGED INTO A FORCE TRIAD GENERATOR AND TESTED ON SIMULATED TISSUE WITH ACCEPTABLE RESULTS. ADDITIONAL TESTING WAS PERFORMED ON PORCINE KIDNEY VESSELS OF VARYING DIAMETER AND THE DEVICE FUNCTIONED NORMALLY. MULTIPLE SEAL CYCLES WERE COMPLETED SATISFACTORILY AND END TONES WERE HEARD INDICATING COMPLETED ACTIVATION CYCLES. A FULL THERMAL EFFECT WAS VISUALLY VERIFIED. THE INVESTIGATION FOUND THE DEVICE TO FUNCTION NORMALLY AND WITHIN SPECIFICATIONS. THE IFU STATES, THE LEVER MUST BE CONTINUALLY HELD WITH THE ACTIVATION BUTTON FULLY DEPRESSED UNTIL THE SEAL CYCLE IS COMPLETE. THE LEVER DOES NOT LATCH INTO THE ACTIVATION POSITION. THERE ARE MANY FACTORS THAT AFFECT SEAL QUALITY. REFER TO THE PRODUCT INSTRUCTIONS FOR USE THAT ADDRESSES TISSUE SEALING RECOMMENDATIONS. MANUFACTURING NON-CONFORMANCES WERE REVIEWED AND NO ENTRIES PERTINENT TO THE CUSTOMER'S REPORT WERE NOTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A NEPHRECTOMY PROCEDURE, AFTER A FEW SEALS WERE COMPLETED, THE PHYSICIAN CUT THE TISSUE AFTER HEARING AN END TONE. THE PHYSICIAN NOTED OOZING BLEEDING AT THE SEAL LINE. ANOTHER DEVICE WAS OPENED TO CONTROL THE OOZING BLEEDING. THERE WAS NO PATIENT HARM. OPERATING TIME WAS NOT EXTENDED FOR MORE THAN 30 MINUTES. THERE WAS NO ADDITIONAL TISSUE RESECTION AND NOTHING FELL INTO THE CAVITY. THE DEVICE WAS RECOGNIZED BY GENERATOR, ACTIVATED WITH A SEALING TONE AND END TONES, INDICATING A COMPLETED SEAL CYCLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    365898 MARYLAND JAW OPEN (23CM) LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP LF1723 43290304X

    Patients

    Seq Age Sex Outcome Treatment
    1