BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EB215, VOYANT MARYLAND FUSION 37CM, 6/BX

    MDR report key: 18069930 · Received November 3, 2023

    Report

    Report Number
    2027111-2023-00705
    Event Type
    Malfunction
    Date Received
    November 3, 2023
    Date of Event
    September 5, 2023
    Report Date
    March 26, 2024
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    GEI
    UDI-DI
    00607915139353
    PMA / PMN Number
    K200598
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT DEVICE HAS RETURNED TO APPLIED MEDICAL FOR EVALUATION. A FOLLOW-UP REPORT WILL BE PROVIDED UPON COMPLETION OF INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THE EVENT UNIT WAS RETURNED TO APPLIED MEDICAL FOR EVALUATION. TESTING WAS PERFORMED ON THE RETURNED UNIT. HOWEVER, THE COMPLAINANT¿S EXPERIENCE OF APPARENT LOW RF ENERGY OUTPUT COULD NOT BE CONFIRMED AS THE EVENT UNIT PASSED ALL RELEVANT TESTING. APPLIED MEDICAL HAS REVIEWED THE DETAILS SURROUNDING THE EVENT AND RELATED PRODUCTS AND IS UNABLE TO DETERMINE THE ROOT CAUSE OF THE OF THE REPORTED EVENT BASED ON THE EVALUATION OF THE RETURNED UNIT.

    Description of Event or Problem · 0

    PROCEDURE PERFORMED: LAP. SIGMA EVENT DESCRIPTION: COMPLAINT 1 OF 3: (B)(4). COMPLAINT 2 OF 3: (B)(4). COMPLAINT 3 OF 3: (B)(4). THE EB215 HAS NOT PERFORMED ANY SEALING WHEN THE CE SEALING PROCESS WAS TRIGGERED. THIS WAS TRIED A FEW TIMES WITH THIS HANDLE BUT NO SEALING OCCURRED. THIS IS REPORT 1 OF 3. A TOTAL OF 3 HANDLES WERE ATTEMPTED. ADDITIONAL INFORMATION RECEIVED BY APPLIED MEDICAL REP VIA EMAIL 4OCT23: ALL TISSUES AROUND THE INTESTINE. THE DEVICE HAS BEEN USED FOR 20 MINUTES. THEY HEARD THE ACTIVATION TONE AND END TONE EVERY TIME. BEFORE YES THE THERMAL EFFECTS WERE VISIBLE AFTER THE 20 MIN NO. ADDITIONAL INFORMATION RECEIVED BY APPLIED MEDICAL REP VIA PHONE 5OCT23: THE ACTIVATION TONE AND END TONE CONTINUED EVEN AFTER THE DEVICES WEREN¿T SEALING ANYMORE. ADDITIONAL INFORMATION RECEIVED BY APPLIED MEDICAL REP VIA EMAIL 13OCT23: NO BLEEDING. NO ALARMS/ERRORS. I WAS IN THE OPERATING ROOM MYSELF AFTER THIS INCIDENT AND CHECKED THE GENERATOR. THIS WORKS WITHOUT PROBLEMS. INTERVENTION: DEVICE REPLACEMENT. PATIENT STATUS: NOTHING (HAPPENED).

    Description of Event or Problem · 0

    PROCEDURE PERFORMED: LAP. SIGMA EVENT DESCRIPTION: COMPLAINT 1 OF 3: 2023-002623 [MFR #2027111-2023-00705] COMPLAINT 2 OF 3: 2023-002624 [MFR #2027111-2023-00702] COMPLAINT 3 OF 3: 2023-002625 [MFR #2027111-2023-00703] THE EB215 HAS NOT PERFORMED ANY SEALING WHEN THE CE SEALING PROCESS WAS TRIGGERED. THIS WAS TRIED A FEW TIMES WITH THIS HANDLE BUT NO SEALING OCCURRED. THIS IS REPORT 1 OF 3. A TOTAL OF 3 HANDLES WERE ATTEMPTED. ADDITIONAL INFORMATION RECEIVED BY APPLIED MEDICAL REP VIA EMAIL 4OCT23: ALL TISSUES AROUND THE INTESTINE. THE DEVICE HAS BEEN USED FOR 20 MINUTES. THEY HEARD THE ACTIVATION TONE AND END TONE EVERY TIME. BEFORE YES THE THERMAL EFFECTS WERE VISIBLE AFTER THE 20 MIN NO. ADDITIONAL INFORMATION RECEIVED BY APPLIED MEDICAL REP VIA PHONE 5OCT23: THE ACTIVATION TONE AND END TONE CONTINUED EVEN AFTER THE DEVICES WEREN¿T SEALING ANYMORE. ADDITIONAL INFORMATION RECEIVED BY APPLIED MEDICAL REP VIA EMAIL 13OCT23: NO BLEEDING. NO ALARMS/ERRORS. I WAS IN THE OPERATING ROOM MYSELF AFTER THIS INCIDENT AND CHECKED THE GENERATOR. THIS WORKS WITHOUT PROBLEMS. INTERVENTION: DEVICE REPLACEMENT PATIENT STATUS: NOTHING (HAPPENED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1960534 EB215, VOYANT MARYLAND FUSION 37CM, 6/BX ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI APPLIED MEDICAL RESOURCES EB215 1482874 00607915139353

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown GENERATOR