BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE ATLAS HANDSWITCHING 37CM

    MDR report key: 4240915 · Received November 10, 2014

    Report

    Report Number
    3006451981-2014-00772
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Date of Event
    May 28, 2014
    Report Date
    October 22, 2014
    Manufacturer
    COVIDIEN LLC (SHANGHAI)
    Product Code
    GEI
    PMA / PMN Number
    K043273
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RETURN OF THE INCIDENT SAMPLE HAS BEEN REQUESTED. TO DATE IT HAS NOT BEEN RECEIVED FOR EVALUATION. ADDITIONAL QUESTIONS IN REGARD TO THE INCIDENT HAVE ALSO BEEN ASKED. IF THE SAMPLE IS RECEIVED OR IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF INITIAL REPORT : (B)(6) 2014. DATE OF FINAL REPORT : 09/13/2016. ONE USED LS1037 LIGASURE DEVICE WAS RECEIVED, AND EVALUATION OF THE RETURNED SAMPLE COULD NOT CONFIRM THE REPORTED ISSUE. VISUAL INSPECTION OF THE DEVICE FOUND NO DEFECTS, AND THE JAWS WERE OPEN UPON RECEIPT. MECHANICAL TESTING CONFIRMED THE JAWS OPENED AND CLOSED NORMALLY USING THE HANDLE, AND THE KNIFE WOULD EXTEND AND RETRACT WITHOUT DIFFICULTY. THE INVESTIGATION FOUND THE DEVICE TO FUNCTION NORMALLY AND WITHIN SPECIFICATIONS. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THIS LOT FOUND NO POTENTIALLY CONTRIBUTING FACTORS, AND THAT IT WAS RELEASED UPON MEETING ALL QUALITY SPECIFICATIONS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A PROCEDURE, AFTER SEALING TISSUE, THE JAWS OF THE DEVICE COULD NOT BE REOPENED WHILE APPLIED TO PATIENT TISSUE. THE SURGEON HAD TO FORCE THE JAWS OPEN WITH ANOTHER INSTRUMENT. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722847 LIGASURE ATLAS HANDSWITCHING 37CM LIGASURE VESSEL SEALING DEVICE GEI COVIDIEN LLC (SHANGHAI) LS1037 S3H0015X

    Patients

    Seq Age Sex Outcome Treatment
    1