BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESOPHYX2 PLUS

    MDR report key: 4269895 · Received November 21, 2014

    Report

    Report Number
    3005473391-2014-00091
    Event Type
    Malfunction
    Date Received
    November 21, 2014
    Date of Event
    November 3, 2014
    Report Date
    November 20, 2014
    Manufacturer
    ENDOGASTRIC SOLUTIONS, INC.
    Product Code
    ODE
    PMA / PMN Number
    K142113
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS DEVICE WORKED NORMALLY AFTER RETAINING BAND WAS SNIPPED, THE DEVICE WAS DISPOSED OF AFTER THE PROCEDURE PER THE HOSPITAL'S STANDARD OPERATING PROCEDURE AND IS NOT AVAILABLE FOR EVALUATION.

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTED THAT DURING THE FIRST FASTENER SET AT THE 11 O'CLOCK POSITION,THE HELICAL RETRACTOR WAS CAUGHT UNDER THE ENDOSCOPE RETAINER BAND. THE PHYSICIAN STATED THE BAND MUST NOT HAVE FLIPPED WHEN THE ENDOSCOPE WAS RETRACTED ONCE IN THE STOMACH, BUT HE THOUGHT IT HAD. THE PHYSICIAN ADVANCED THE HELICAL RETRACTOR WHICH EXITED UNDER THE RETAINER BAND. WHEN THE RETRACTOR WAS PULLED BACK TO BE REPOSITIONED, THE RETAINER BAND HELD THE RETRACTOR OUTSIDE OF THE PROTECTIVE HOME POSITION. THE PHYSICIAN USED AN ENDOSCOPIC SCISSORS IN THE WORKING CHANNEL OF THE ENDOSCOPE TO CUT THE RUBBER RETAINER BAND AND CONTINUED WITH THE PROCEDURE USING THE SAME DEVICE. THERE WERE NO PATIENT ADVERSE AFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    757882 ESOPHYX2 PLUS ODE ODE ENDOGASTRIC SOLUTIONS, INC. C02033-01

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention