BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MVA PUMP TUBING

    MDR report key: 2349721 · Received November 17, 2011

    Report

    Report Number
    1717344-2011-01067
    Event Type
    Malfunction
    Date Received
    November 17, 2011
    Date of Event
    November 15, 2011
    Report Date
    November 15, 2011
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TO DATE THE INCIDENT SAMPLE HAS NOT BEEN RECEIVED FOR EVALUATION. IF THE SAMPLE IS RECEIVED OR IF ADDITIONAL INFO PERTINENT TO THE INCIDENT IS OBTAINED A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE MWA PUMP TUBING IN USE DURING A LAPAROSCOPIC LIVER ABLATION LEAKED ON THE ABLATION PUMP AND THE PUMP STOPPED WORKING. THIS CAUSED A ONE HOUR DELAY IN THE PROCEDURE, AS ANOTHER PUMP NEEDED TO BE LOCATED IN ORDER TO COMPLETE THE PROCEDURE. THERE WAS NO PT INJURY CAUSED BY THE DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MVA PUMP TUBING MICROWAVE ABLATION ACCESSORY GEI COVIDIEN LP (VALLEYLAB) 6117443X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK EVIDENT MW ABLATION PUMP: SERIAL #(B)(4)