BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDLINE RENEWAL REPROCESSED ENT COBLATOR

    MDR report key: 6088188 · Received November 8, 2016

    Report

    Report Number
    3032391-2016-00028
    Event Type
    Malfunction
    Date Received
    November 8, 2016
    Date of Event
    September 15, 2016
    Report Date
    November 8, 2016
    Manufacturer
    MEDLINE RENEWAL
    Product Code
    GEI
    PMA / PMN Number
    K100543
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 ARTHROCARE ENT COBLATOR II PROCISE XP WAND, W/INTEGRATED CABLE, SUCTION & SALINE, (BLUE), PART # EIC8872-01. WE PERFORMED A THOROUGH INSPECTION OF THE DEVICE AND COMPLETED AN INVESTIGATION INTO THE INCIDENT. OUR INVESTIGATION CONFIRMED THAT THE ARTHROCARE ENT COBLATOR II PROCISE XP WAND DID NOT FUNCTION AS EXPECTED, AND THE REPORTED ISSUE WAS CONFIRMED. MEDLINE RENEWAL DETERMINED THAT THE SALINE LINE HAD NOT BEEN REASSEMBLED CORRECTLY, CAUSING A BLOCKAGE IN THE LINE AND PREVENTING FLOW. THE MANUFACTURING DEFICIENCY HAS SINCE BEEN CORRECTED. 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 TO OBTAIN A NEW DEVICE, MEDLINE RENEWAL IS FILING THIS MEDWATCH REPORT. THIS MEDWATCH REPORT WAS ORIGINALLY SUBMITTED ON 10/18/2016, HOWEVER DUE TO AN INTERNAL ERROR, THIS REPORT WAS SUBMITTED THROUGH THE ESG TEST ACCOUNT INSTEAD OF THE ESG PRODUCTION ACCOUNT. CONSEQUENTLY, CDRH DID NOT RECEIVE THIS REPORT WITHIN THE 30 DAY TIMEFRAME. THEREFORE, THIS MEDWATCH REPORT NOW REFLECTS TODAY'S DATE WHICH CORRESPONDS WITH THE FILE TRANSMISSION THROUGH THE ESG PRODUCTION ACCOUNT.

    Description of Event or Problem · 1

    MEDLINE RENEWAL RECEIVED A REPORT INDICATING THAT THE REPROCESSED ENT COBLATOR II PROCISE XP WAND WOULD NOT PRIME, THEREFORE, NO SALINE WOULD FLOW THROUGH THE DEVICE TO THE TIP BEFORE 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
    737700 MEDLINE RENEWAL REPROCESSED ENT COBLATOR ENT ABLATION WAND GEI MEDLINE RENEWAL EIC 8872-01 314729

    Patients

    Seq Age Sex Outcome Treatment
    1