BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EA020, VOYANT GENERATOR, 1/BX

    MDR report key: 9317487 · Received November 13, 2019

    Report

    Report Number
    2027111-2019-00632
    Event Type
    Malfunction
    Date Received
    November 13, 2019
    Date of Event
    October 16, 2019
    Report Date
    January 22, 2020
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    GEI
    UDI-DI
    10060795137601
    PMA / PMN Number
    K182244
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT UNIT WAS RETURNED TO APPLIED MEDICAL FOR EVALUATION. ENGINEERING WAS ABLE TO REPLICATE THE COMPLAINANT'S EXPERIENCE BY ACTIVATING THE DEVICE ON THICK MATERIAL. THE DATA LOG FROM THE EVENT UNIT WAS PULLED AND NO ERROR CODES WERE FOUND. THE EVENT UNIT MET CURRENT SPECIFICATIONS AND THERE WERE NO VISIBLE NON-CONFORMANCES. BASED ON THE CONDITION OF THE RETURNED UNIT AND THE DESCRIPTION OF THE EVENT, THE COMPLAINANT DID NOT HEAR THE END TONE BECAUSE THE ACTIVATION BUTTON WAS RELEASED BEFORE THE END TONE COULD BE TRIGGERED. THIS EVENT WAS DETERMINED TO BE REPORTABLE BASED ON THE ORIGINAL DESCRIPTION OF THE EVENT. HOWEVER, UPON EVALUATION OF THE EVENT UNIT, THE EVENT IS DEEMED NOT REPORTABLE AS IT IS UNLIKELY TO CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 0

    NAME OF PROCEDURE: TAH. THE REP WAS IN THE CASE, WHICH WAS A VOYANT EVALUATION. ON ACTIVATION 17 AND 21, RECEIVED 2 LONG SEAL CYCLES THAT DIDN¿T HAVE AN END TONE. ON EACH OF THESE OCCURRENCES, TOOK FINGER OFF THE ACTIVATION BUTTON TO END THE LONG SEAL CYCLE. THERE WERE NO ERROR CODES DISPLAYED ON THE GENERATOR. COMPLETED THE CASE WITH THE GENERATOR AND THEN PULLED IT FOR RETURN. THE EB240 (LOT# 1366079) WAS USED AND DISCARDED AFTER THE CASE. INTERVENTION: COMPLETED THE CASE WITH THE SAME DEVICE. PATIENT STATUS: FINE.

    Additional Manufacturer Narrative · 1

    ENGINEERING IS INVESTIGATING THE RETURNED UNIT. A FINAL REPORT WILL BE SENT ONCE THE RESULTS HAVE BEEN ANALYZED.

    Description of Event or Problem · 1

    NAME OF PROCEDURE: TAH. THE REP WAS IN THE CASE, WHICH WAS A VOYANT EVALUATION. ON ACTIVATION 17 AND 21, RECEIVED 2 LONG SEAL CYCLES THAT DIDN¿T HAVE AN END TONE. ON EACH OF THESE OCCURRENCES, TOOK FINGER OFF THE ACTIVATION BUTTON TO END THE LONG SEAL CYCLE. THERE WERE NO ERROR CODES DISPLAYED ON THE GENERATOR. COMPLETED THE CASE WITH THE GENERATOR AND THEN PULLED IT FOR RETURN. THE EB240 (LOT# 1366079) WAS USED AND DISCARDED AFTER THE CASE. INTERVENTION: COMPLETED THE CASE WITH THE SAME DEVICE. PATIENT STATUS: FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1113171 EA020, VOYANT GENERATOR, 1/BX ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI APPLIED MEDICAL RESOURCES EA020 1355150 10060795137601

    Patients

    Seq Age Sex Outcome Treatment
    1 EB240