BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1221934-2018-50962

    MDR report key: 7655032 · Received July 2, 2018

    Report

    Report Number
    1221934-2018-50962
    Event Type
    Malfunction
    Date Received
    July 2, 2018
    Date of Event
    May 21, 2013
    Report Date
    May 21, 2013
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. THERE WERE NO ANOMALIES FOUND AND NO FAILURE WAS REPORTED FOR THIS PART. THIS REPORT IS BEING FILED FROM THE REMETREX COMPLAINT MANAGEMENT SYSTEM AS REQUIRED UNDER MITEK'S CORRECTIVE AND PREVENTATIVE ACTIONS (CAPA) TO FILE USA FDA MDR MISSED MALFUNCTIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED BY OUR AFFILIATE PARTS OF THE BRIDGE CAME APART AND SMALL SPRING WAS LOST OF THE X-PLORE DEVICE AND THE SHEATH COULDN'T BE USED ANYMORE. THIS HAPPENED BEFORE USE ON THE PATIENT. THE PROCEDURE WAS CONTINUED AND SUCCESSFULLY COMPLETED WITH A LIKE DEVICE. NO PATIENT HARM OR CLINICALLY RELEVANT INCREASE IN PROCEDURE DURATION REPORTED. PLEASE SEE ALSO MEDWATCH REPORT 1221934-2018-50961.

    Patients

    Seq Age Sex Outcome Treatment
    1