BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDLINE RENEWAL REPROCESSED LIGASURE IMPACT

    MDR report key: 6089384 · Received November 9, 2016

    Report

    Report Number
    3032391-2016-00026
    Event Type
    Malfunction
    Date Received
    November 9, 2016
    Date of Event
    September 14, 2016
    Report Date
    November 9, 2016
    Manufacturer
    MEDLINE RENEWAL
    Product Code
    NUJ
    PMA / PMN Number
    K153745
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IN QUESTION WAS RETURNED TO MEDLINE RENEWAL FOR EVALUATION, AND WE CONFIRMED THAT IT WAS A MEDLINE RENEWAL REPROCESSED COVIDIEN LIGASURE IMPACT CURVED, LARGE JAW, OPEN SEALER/DIVIDER, MODEL LF4318. WE PERFORMED A THOROUGH INSPECTION AND INVESTIGATION INTO THE INCIDENT. OUR INVESTIGATION CONFIRMED THAT THE DEVICE DID NOT FUNCTION AS EXPECTED, CONFIRMING THE INITIAL INCIDENT REPORT. THE ROOT CAUSE OF THE DEVICE FAILURE IS UNKNOWN AND THE INCIDENT IS STILL UNDER INVESTIGATION. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THEN THIS REPORT WILL BE UPDATED WITH THE NEW INFORMATION. THE CUSTOMER CONFIRMED THAT NO ADVERSE PATIENT CONSEQUENCE OR MEDICAL INTERVENTION WAS REQUIRED AS A RESULT OF THE INCIDENT. HOWEVER, DUE TO THE REPORTED DELAY IN THE PROCEDURE, MEDLINE RENEWAL IS FILING THIS MEDWATCH REPORT. (B)(4).

    Description of Event or Problem · 1

    MEDLINE RENEWAL RECEIVED A REPORT INDICATING THAT A REPROCESSED COVIDIEN LIGASURE IMPACT, MODEL LF4318, SOUNDED INTERMITTENT ALARMS AND PRODUCED LOW ENERGY DURING USE. ANOTHER REPROCESSED DEVICE WAS READILY AVAILABLE TO COMPLETE THE PROCEDURE, THEREFORE NO PATIENT HARM WAS REPORTED AS A RESULT OF THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    742204 MEDLINE RENEWAL REPROCESSED LIGASURE IMPACT TISSUE SEALER/DIVIDER NUJ MEDLINE RENEWAL LF4318 308737

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention