BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDLINE RENEWAL REPROCESSED ARTHROCARE ENT COBLATOR

    MDR report key: 6088132 · Received November 8, 2016

    Report

    Report Number
    3032391-2016-00014
    Event Type
    Malfunction
    Date Received
    November 8, 2016
    Date of Event
    May 10, 2016
    Report Date
    November 8, 2016
    Manufacturer
    MEDLINE RENEWAL
    Product Code
    GEI
    UDI-DI
    10888277382640
    PMA / PMN Number
    K100543
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED DEVICES WERE NOT RETURNED TO MEDLINE RENEWAL FOR EVALUATION AND THE REPORTED ISSUE COULD NOT BE CONFIRMED. MEDLINE RENEWAL DID NOT RECEIVE ANY ADDITIONAL INFORMATION AT THE TIME OF THE REPORTED INCIDENT FROM THE FACILITY. DEVICE HISTORY RECORDS FROM TWO UNOPENED LOTS WERE REVIEWED, AND ALL VALIDATED CLEANING, STERILIZATION, INSPECTION, AND TEST PROCESSES WERE PERFORMED AS REQUIRED PRIOR TO PRODUCT RELEASE. MEDLINE RENEWAL PERFORMED A RETROSPECTIVE REVIEW OF COMPLAINTS AND DETERMINED THAT THIS INCIDENT MET THE CRITERIA FOR MDR REPORTING BUT WAS NOT FILED WITHIN THE REQUIRED 30 DAY TIMEFRAME. ALTHOUGH NO PATIENT HARM WAS REPORTED, MEDICAL INTERVENTION (RUNNING WATER THROUGH THE DEVICE) WAS INDICATED AS A RESULT OF THE INCIDENT. MEDLINE RENEWAL IS THEREFORE RETROSPECTIVELY FILING THIS MEDWATCH REPORT IN AN ABUNDANCE OF CAUTION. THIS MEDWATCH REPORT WAS ORIGINALLY SUBMITTED ON (B)(6) 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. THEREFORE, THIS MEDWATCH REPORT NOW REFLECTS TODAY'S DATE WHICH CORRESPONDS WITH THE FILE TRANSMISSION THROUGH THE ESG PRODUCTION ACCOUNT. DEVICE NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    MEDLINE RENEWAL RECEIVED A REPORT THAT REPROCESSED ENT COBLATORS WERE "SMOKING" IN THE OPERATING ROOM, AND THAT THE USERS RAN WATER THROUGH THE DEVICES IN ORDER TO STOP THE DEVICES FROM SMOKING. THE REPORT STATED THAT NO PATIENTS WERE HARMED IN ANY WAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738240 MEDLINE RENEWAL REPROCESSED ARTHROCARE ENT COBLATOR ENT ABLATION WAND GEI MEDLINE RENEWAL EIC 5872-01 UNKNOWN 10888277382640

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R