BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESOPHYX Z+

    MDR report key: 11675755 · Received April 15, 2021

    Report

    Report Number
    3005473391-2021-00145
    Event Type
    Malfunction
    Date Received
    April 15, 2021
    Date of Event
    March 16, 2021
    Report Date
    March 1, 2024
    Manufacturer
    ENDOGASTRIC SOLUTIONS, INC
    Product Code
    ODE
    UDI-DI
    00810275011089
    PMA / PMN Number
    K172811
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATING TYPE OF INVESTIGATION (B) TO ONLY INCLUDE: 4112, 4109, 4110, 3331, 10, AND 4111.

    Additional Manufacturer Narrative · 0

    THE SEPARATED PORTIONS OF THE RETRACTOR DRIVE CABLE WERE FORENSICALLY ANALYZED TO BETTER DETERMINE HOW THE CABLE SEPARATED. THE REPORT CONCLUDED THE CABLE SEPARATED WHILE IT WAS ROTATED IN THE CLOCKWISE DIRECTION. INCOMING INSPECTION RECORDS FOR THIS COMPONENT LOT SHOW THE DRIVE CABLE MET TORSIONAL DRAWING REQUIREMENTS IN THE CLOCKWISE DIRECTION. THUS, IT IS LIKELY THE CABLE WAS OVER-ROTATED BY THE PHYSICIAN DURING TISSUE ENGAGEMENT.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS AVAILABLE FROM THE HOSPITAL FOR EVALUATION; AN ENGINEERING DEVICE EVALUATION WAS PERFORMED ON THE RETURNED PRODUCT. THE HELICAL RETRACTOR CONTROL (RETRACTOR CONTROL KNOB, RETRACTOR SYSTEM INNER SLIDE TUBE AND A PORTION OF THE RETRACTOR DRIVE CABLE) WERE CONFIRMED TO BE SEPARATED FROM THE DEVICE. THERE IS EVIDENCE THE CABLE WAS OVER STRESSED AND OVER ROTATED DURING USE. THE INVESTIGATION IS IN-PROCESS AND A FOLLOW-UP REPORT WILL BE SUBMITTED UPON INVESTIGATION COMPLETION. THIS COMPLAINT IS BEING REPORTED BECAUSE IF NO INTERVENTION IS PERFORMED, THERE IS A RISK OF A SHARP FOREIGN BODY REMAINING INSIDE THE PATIENT.

    Description of Event or Problem · 1

    THE PHYSICIAN ENGAGED AT LEAST TWO COILS OF THE HELICAL RETRACTOR INTO THE GEJ AND UPON TISSUE RETRACTION, THE RETRACTOR CONTROL DISCONNECTED FROM THE DEVICE. AN ENDOGASTRIC SOLUTIONS (EGS) CLINICAL TRAINING & EDUCATION MANAGER WAS CONTACTED AND PROVIDED GUIDANCE FOR DISENGAGING THE HELIX FROM TISSUE SANS RETRACTOR CONTROL. THE PHYSICIAN DECIDED TO PULL THE HELIX FROM THE TISSUE. THE DEVICE WAS UNEVENTFULLY REMOVED WITH THE HELIX LOOSELY HANGING JUST DISTAL TO THE TISSUE MOLD TIP. AN UNKNOWN NUMBER OF ENDOCLIPS WERE PLACED WHERE THE HELIX WAS LOCATED, BUT THE PLACEMENT OF THE CLIPS WAS OUT OF AN ABUNDANCE OF CAUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    566525 ESOPHYX Z+ ODE ODE ENDOGASTRIC SOLUTIONS, INC R2007 402755 00810275011089

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Required Intervention