BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ERBE MODEL ECO2

    MDR report key: 11102576 · Received December 31, 2020

    Report

    Report Number
    3002882053-2020-00001
    Event Type
    Injury
    Date Received
    December 31, 2020
    Date of Event
    November 30, 2020
    Report Date
    December 30, 2020
    Manufacturer
    NEXTPHASE MEDICAL DEVICES LLC
    Product Code
    FCX
    PMA / PMN Number
    K162332
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS FOUND TO BE FUNCTIONING AS INTENDED THE EVALUATION INCLUDED AN ELECTRICAL SAFETY CHECK, A FUNCTIONAL CHECK OF EACH OF THE EQUIPMENT'S FEATURES AS WELL AS FLOWRATE OUTPUT CHECK. THE DEVICE IS WITHIN SPECIFICATION AND ALL FEATURES ARE FUNCTIONING PROPERLY. IN ADDITION, NO ANOMALIES WERE FOUND IN THE DEVICE HISTORY RECORD (DHR) OF THE INVOLVED DEVICE. IN CONCLUSION, NO EQUIPMENT PROBLEM WAS FOUND THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE EVENT. NO DETERMINATION COULD BE MADE AS TO THE CAUSE OF THE EVENT. NEVERTHELESS, AN EMBOLISM IS A POSSIBILITY WHEN USING AN INSUFFLATOR AND THERE IS A WARNING IN THE USER MANUAL ADDRESSING THIS TYPE OF SITUATION ("PROCEDURAL CONCERNS - PATIENT HISTORY AND GENERAL PROCEDURE AWARENESS IS ESSENTIAL TO OVERALL PROCEDURE SAFETY. SHOULD ACCIDENTAL INTRAVASATION OF CO2 OCCUR, IN RARE CIRCUMSTANCES, IT CAN RESULT IN EMBOLISM."). NO TRENDS HAVE BEEN IDENTIFIED AND NEXTPHASE IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT INCIDENT OCCURRED WITH THE ENDOSCOPIC CO2 INSUFFLATOR DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE. THE UNIT'S FLOWRATE WAS SET ON MEDIUM. IT WAS SOMEWHAT OF A DIFFICULT CANNULATION. EVENTUALLY THE BILE DUCT WAS DRAINED. AT THE TAIL END OF THE PROCEDURE, THE PATIENT BECAME VERY HYPOTENSIVE (I.E., LOW BLOOD PRESSURE) REQUIRING THE PROCEDURE TO BE ABORTED PREMATURELY. THE PATIENT'S SKIN MOTTLED AND HE COULD NOT BE EXTUBATED. EVENTUALLY, AFTER GOING TO THE ICU, HE IMPROVED SIGNIFICANTLY AND WITHIN A SHORT PERIOD OF TIME (LESS THAN 12 HOURS) WHICH IS WHY A CO2 EMBOLUS IS SUSPECTED. 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
    1567903 ERBE MODEL ECO2 ENDOSCOPIC CO2 INSUFFLATOR FCX NEXTPHASE MEDICAL DEVICES LLC ECO2

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| L