BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESUCTION, ESOPHAGEAL

    MDR report key: 9552578 · Received January 3, 2020

    Report

    Report Number
    MW5092027
    Event Type
    Injury
    Date Received
    January 3, 2020
    Date of Event
    December 20, 2019
    Report Date
    December 30, 2019
    Manufacturer
    ENDO-THERAPEUTICS, INC.
    Product Code
    FGX
    Report Source
    Voluntary report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PRESENTED WITH FOOD BOLUS. SNARE WAS USED TO ATTEMPT REMOVAL BUT WAS TOO SMALL TO ENCIRCLE THE BOLUS. AN E-SUCTION CAP DEVICE WAS THEN APPLIED TO THE TIP OF THE SCOPE. THE SCOPE WAS THEN ADVANCED BACK INTO THE CERVICAL ESOPHAGUS. THE BOLUS WAS SUCTIONED INTO THE CAP BUT THE WIRE OF THE DEVICE FAILED AND THE CAP DISLODGED ON TOP OF THE FOOD BOLUS. THIS WAS IMMEDIATELY BELOW THE UPPER ESOPHAGEAL SPHINCTER. PROVIDER WAS UNABLE TO REMOVE THIS DUE TO PT RETCHING AND RISK OF AIRWAY OBSTRUCTION. ANESTHESIA WAS CALLED AND THE PT WAS INTUBATED AND TRANSFERRED TO THE ED WITH INTENTION OF TRANSFER TO A TERTIARY CARE FACILITY WHERE ACCEPTING ENT REMOVED THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11795 ESUCTION, ESOPHAGEAL SNARE, NON-ELECTRICAL FGX ENDO-THERAPEUTICS, INC. ET2000 336750

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Other| R