BEUDAMED
    FDA Adverse Event Death Summary report: N

    ERBE MODEL ECO2

    MDR report key: 11495038 · Received March 16, 2021

    Report

    Report Number
    3002882053-2021-00001
    Event Type
    Death
    Date Received
    March 16, 2021
    Date of Event
    December 31, 2020
    Report Date
    March 15, 2021
    Manufacturer
    NEXTPHASE MEDICAL DEVICES LLC
    Product Code
    FCX
    PMA / PMN Number
    K162332
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THEREFORE, NO DETERMINATION COULD BE MADE AS TO THE ROOT CAUSE OF THE EVENT. NEXTPHASE IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 1

    PER ORAL ENDOSCOPIC MYOTOMY WAS PERFORMED ON PATIENT. PATIENT HAS A HISTORY OF CARDIAC ISSUES. POSTERIOR APPROACH FAILED POEM PREVIOUSLY AND THEREFORE ANTERIOR APPROACH WAS TAKEN. DUE TO PRIOR TREATMENT, SEVERE FIBROSIS WAS ENCOUNTERED. DURING THE RETROGRADE MYOTOMY, PATIENT EXPERIENCED CARDIAC ISSUES. IMMEDIATE RESPONSE BY TRAUMA TEAM ENSUED, PATIENT WAS DEEMED BRAIN DEAD SHORTLY AFTER AND AFTER 11 DAY STAY IN ICU EXPIRED. STAFF DOES NOT NEED EQUIPMENT EVALUATED, STATED THERE WAS NO ISSUE WITH THE PERFORMANCE OF EQUIPMENT USED. PLEASE NOTE, THE NEXCORE GI INSUFFLATOR MODEL NX-350 IS PRIVATELY LABELED FOR ERBE USA, INC. AS ERBE MODEL ECO2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391619 ERBE MODEL ECO2 ENDOSCOPIC CO2 INSUFFLATOR FCX NEXTPHASE MEDICAL DEVICES LLC ECO2

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death