BEUDAMED
    FDA Adverse Event Summary report: N

    MEDIVATORS DSD EDGE

    MDR report key: 3841537 · Received May 30, 2014

    Report

    Report Number
    2150060-2014-00019
    Date Received
    May 30, 2014
    Date of Event
    May 5, 2014
    Report Date
    May 28, 2014
    Manufacturer
    MEDIVATORS
    Product Code
    FEB
    PMA / PMN Number
    K092387
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSICIAN REPORTED THAT AFTER AN ENDOSCOPY PROCEDURE A PATIENT HAD BURNS THAT WERE NOT APPARENT AT THE START OF THE PROCEDURE. POTENTIAL CASE OF CHEMICAL COLITIS. MEDIVATORS FIELD SERVICE ENGINEER VISITED THE FACILITY AND CONFIRMED THAT THE MEDIVATORS DSD EDGE AER MACHINE WAS RUNNING AND RINSING SCOPES ACCORDING TO SPECIFICATIONS. TEST CYCLE WERE RUN TO VERIFY PERFORMANCE. BASINS OF THE AER WERE TESTED FOR CHEMICAL REACTION. IT WAS REPORTED THAT NO ERRORS WERE FOUND. THE CAUSE OF THE BURNS ON THE PATIENT ARE UNKNOWN. THERE IS LIMITED INFORMATION AVAILABLE FOR THIS INCIDENT. THIS POTENTIAL COMPLAINT WILL CONTINUE TO BE MONITORED WITHIN THE MEDIVATORS COMPLAINT SYSTEM.

    Description of Event or Problem · 1

    PHYSICIAN REPORTED THAT AFTER A PROCEDURE, A PATIENT HAD BURNS THAT WERE NOT APPARENT AT THE START OF THE PROCEDURE. POTENTIAL CASE OF CHEMICAL COLITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317926 MEDIVATORS DSD EDGE AUTOMATED ENDOSCOPE REPROCESSOR FEB MEDIVATORS DSD-EDGE

    Patients

    Seq Age Sex Outcome Treatment
    1 RAPICIDE PA