BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DSD-201

    MDR report key: 7097990 · Received December 7, 2017

    Report

    Report Number
    2150060-2017-00051
    Event Type
    Injury
    Date Received
    December 7, 2017
    Date of Event
    November 9, 2017
    Report Date
    December 7, 2017
    Manufacturer
    MEDIVATORS INC.
    Product Code
    FEB
    UDI-DI
    00677964033858
    PMA / PMN Number
    K914145
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FACILITY REPORTED PERFORMING AN ENDOSCOPY PROCEDURE ON A PATIENT WITH AN ENDOSCOPE WHICH WAS REPROCESSED IN THEIR DSD-201 AUTOMATED ENDOSCOPE REPROCESSOR. DURING THE PROCEDURE TISSUE WAS FOUND WITHIN THE ENDOSCOPE SUSPECTED TO BE FROM A PREVIOUS PATIENT. THIS IS POTENTIAL FOR PATIENT CROSS-CONTAMINATION. THE INITIAL REPORTER CHECKED THE OPERATIONS OF THEIR DSD-201 AER AND DETERMINED ALL SETTINGS AND OPERATIONS WERE FUNCTIONING PROPERLY. HE REPORTED UNDERSTANDING THIS EVENT IS RELATED TO IMPROPER PRE-CLEANING OF THE ENDOSCOPE. HE STATED THE FACILITY DOES NOT HAVE ANY QUESTIONS OR CONCERNS REGARDING THE MEDIVATORS AER. THERE WAS NO REPORT OF PATIENT HARM AND NO REPORT OF ADDITIONAL MEDICAL ATTENTION BEING SOUGHT BY THE PATIENT. THIS COMPLAINT WILL CONTINUE TO BE MONITORED IN THE MEDIVATORS COMPLAINT HANDLING SYSTEM.

    Description of Event or Problem · 1

    THE FACILITY REPORTED THAT WHILE PERFORMING AN ENDOSCOPY PROCEDURE, TISSUE WAS FOUND IN THE ENDOSCOPE FROM THE PREVIOUS PATIENT. THIS INDICATES IMPROPER PRE-CLEANING. THERE IS A POTENTIAL FOR PATIENT CROSS-CONTAMINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    874653 DSD-201 AUTOMATED ENDOSCOPE REPROCESSOR FEB MEDIVATORS INC. 00677964033858

    Patients

    Seq Age Sex Outcome Treatment
    1 Other