BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VOYANT® FINE FUSION DEVICE

    MDR report key: 20102098 · Received August 29, 2024

    Report

    Report Number
    2027111-2024-00813
    Event Type
    Injury
    Date Received
    August 29, 2024
    Report Date
    December 6, 2024
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    GEI
    UDI-DI
    00607915138240
    PMA / PMN Number
    K202818
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT UNIT WAS NOT RETURNED TO APPLIED MEDICAL FOR EVALUATION. AS THE EVENT UNIT WAS NOT RETURNED, APPLIED MEDICAL IS UNABLE TO DETERMINE IF THE EVENT UNIT EXHIBITED ANY NON-CONFORMANCES THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. IN THE ABSENCE OF THE EVENT UNIT, IT IS DIFFICULT TO DETERMINE IF THE REPORTED EVENT WAS CAUSED BY A MANUFACTURING NON-CONFORMANCE OR CIRCUMSTANTIAL FACTORS AT THE TIME OF USE. APPLIED MEDICAL HAS REVIEWED THE DETAILS SURROUNDING THE EVENT AND IS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE EVENT. APPLIED MEDICAL HAS PERFORMED A HISTORICAL TREND ANALYSIS AND REVIEW OF PRODUCTION RECORDS AND NO RELEVANT DOCUMENTS WERE IDENTIFIED. THE PROBABILITY AND CRITICALITY OF THE HARM RESULTING FROM THIS EVENT HAVE BEEN EVALUATED AND WERE FOUND TO BE AT AN ACCEPTABLE LEVEL.

    Additional Manufacturer Narrative · 0

    THE EVENT UNIT IS NOT RETURNING TO APPLIED MEDICAL FOR EVALUATION. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF INVESTIGATION.

    Description of Event or Problem · 0

    PROCEDURE PERFORMED: THYROIDECTOMY. *EVENT DATE IS UNKNOWN* EVENT DESCRIPTION: COMPLAINT 1 OF 7: (B)(4). IN A CASE STUDY IN A HOSPITAL IN PORTUGAL, THE SURGEON HAPPENED TO MENTION THAT IN THE PAST YEAR THEY'VE HAD 7 POST OP BLEEDING CASES WHILE USING A VOYANT HANDPIECE (TO BE CONFIRMED WHICH ONE, MOST LIKELY FINE FUSION). ADDITIONAL INFORMATION RECEIVED FROM COMPANY REP. VIA PCF ON 22AUG24: THE SURGEONS INFORMED THAT LAST YEAR HAD SOME POST OP BLEEDING AND THE PATIENTS WENT AGAIN TO THE OR. COULDN'T SPECIFY IF THE EVENT WAS VOYANT RELATED. SURGEON IS GOING TO SEE THE FILES AND INFORM ASAP IF IT WERE SURGERIES WHERE VOYANT WERE USED. NO NEED A CLOSING LETTER. ADDITIONAL INFORMATION FROM CALL WITH COMPANY REP. ON 27AUG24 (SEE ATTACHMENT "2024-002142 - 2024-002148 CALL DISCUSSION SUMMARY 27AUG24") 7 POST-OPERATIVE BLEEDING EVENTS HAPPENED SOMETIME LAST YEAR (2023); THE SPECIFIC EVENT DATES ARE UNKNOWN. THE COMPLICATIONS ARE PROBABLY LINKED TO THE USE OF VOYANT HANDPIECES: STILL YET TO BE CONFIRMED WITH THE SURGEON. THE PATIENTS ARE FINE, AND THE POST-OPERATIVE BLEEDING COMPLICATIONS WERE SUCCESSFULLY TREATED. GIVEN THAT THESE EVENTS HAPPENED RELATIVELY LONG AGO, THE FAULTY DEVICES ARE UNLIKELY TO BE RECOVERED AND WON¿T BE AVAILABLE FOR INVESTIGATION. NO ¿CONFIRMATION OF RECEIPT¿ IS NEEDED AT THIS POINT AND NO CLOSING LETTER HAS BEEN REQUESTED. TYPE OF INTERVENTION: PATIENTS WENT AGAIN TO THE OR. PATIENT STATUS: POST-OPERATIVE BLEEDING.

    Description of Event or Problem · 0

    PROCEDURE PERFORMED: THYROIDECTOMY *EVENT DATE IS UNKNOWN* EVENT DESCRIPTION: COMPLAINT 1 OF 7:(B)(4). IN A CASE STUDY IN A HOSPITAL IN (B)(6), THE SURGEON HAPPENED TO MENTION THAT IN THE PAST YEAR THEY'VE HAD 7 POST OP BLEEDING CASES WHILE USING A VOYANT HANDPIECE (TO BE CONFIRMED WHICH ONE, MOST LIKELY FINE FUSION). ADDITIONAL INFORMATION RECEIVED FROM COMPANY REP. VIA PCF ON 22AUG24: THE SURGEONS INFORMED THAT LAST YEAR HAD SOME POST OP BLEEDING AND THE PATIENTS WENT AGAIN TO THE OR. COULDN'T SPECIFY IF THE EVENT WAS VOYANT RELATED. SURGEON IS GOING TO SEE THE FILES AND INFORM ASAP IF IT WERE SURGERIES WHERE VOYANT WERE USED. NO NEED A CLOSING LETTER. ADDITIONAL INFORMATION FROM CALL WITH COMPANY REP. ON 27AUG24 (SEE ATTACHMENT "2024-002142 - 2024-002148 CALL DISCUSSION SUMMARY 27AUG24") 7 POST-OPERATIVE BLEEDING EVENTS HAPPENED SOMETIME LAST YEAR (2023); THE SPECIFIC EVENT DATES ARE UNKNOWN. THE COMPLICATIONS ARE PROBABLY LINKED TO THE USE OF VOYANT HANDPIECES: STILL YET TO BE CONFIRMED WITH THE SURGEON. THE PATIENTS ARE FINE, AND THE POST-OPERATIVE BLEEDING COMPLICATIONS WERE SUCCESSFULLY TREATED. GIVEN THAT THESE EVENTS HAPPENED RELATIVELY LONG AGO, THE FAULTY DEVICES ARE UNLIKELY TO BE RECOVERED AND WON¿T BE AVAILABLE FOR INVESTIGATION. NO ¿CONFIRMATION OF RECEIPT¿ IS NEEDED AT THIS POINT AND NO CLOSING LETTER HAS BEEN REQUESTED. TYPE OF INTERVENTION: PATIENTS WENT AGAIN TO THE OR PATIENT STATUS: POST-OPERATIVE BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1989935 VOYANT® FINE FUSION DEVICE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI APPLIED MEDICAL RESOURCES EB230 NI 00607915138240

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization