MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES VOYANT® FINE FUSION DEVICE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	EB230
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Hematoma (1884)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The event unit is not returning to applied medical for evaluation.Lot information was not provided.A follow-up report will be submitted upon completion of investigation.
Event or Problem Description
Procedure performed: thyroidectomy.Event description: this is not a single event, but a complaint received by email from the customer, today.This is a free translation from the email receive: ¿i don't feel comfortable using the voyant machine due to previous cases of post-operative hematoma.Despite being described as possible complications, the incidence increased in relation to the literature when i used this device.I emphasize that these are outpatients with an increased risk of bleeding at home and airway compromise.In addition to forcing me to ligate everything a second time with vicryl and therefore longer surgery time, more costs, it also forces me to discharge patients with a drain to ensure airway patency.This is uncomfortable for the patient.The voyant device simultaneously sticks to the tissues, causing tearing instead of sealing.¿ additional information received by phone from the territory manager on 11feb2025: this will not be possible to obtain any additional information on this complaint as this is an anonymous declaration received by the warehouse logistic department meaning that we will not be able to reach out to any specific surgeon regarding this matter.The date of event indicated on the product complaint form was the date the declaration was communicated by the warehouse logistic department.Type of intervention: unknown.Patient status: post-operative hematoma.
Additional Manufacturer Narrative
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 trends 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.
Event or Problem Description
Procedure performed: thyroidectomy.Event description: this is not a single event, but a complaint received by email from the customer, today.This is a free translation from the email receive: ¿i don't feel comfortable using the voyant machine due to previous cases of post-operative hematoma.Despite being described as possible complications, the incidence increased in relation to the literature when i used this device.I emphasize that these are outpatients with an increased risk of bleeding at home and airway compromise.In addition to forcing me to ligate everything a second time with vicryl and therefore longer surgery time, more costs, it also forces me to discharge patients with a drain to ensure airway patency.This is uncomfortable for the patient.The voyant device simultaneously sticks to the tissues, causing tearing instead of sealing.¿ additional information received by phone from the territory manager on 11feb25: this will not be possible to obtain any additional information on this complaint as this is an anonymous declaration received by the warehouse logistic department meaning that we will not be able to reach out to any specific surgeon regarding this matter.The date of event indicated on the product complaint form was the date the declaration was communicated by the warehouse logistic department.Type of intervention: unknown.Patient status: post-operative hematoma.

• Brand Name: VOYANT® FINE FUSION DEVICE
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: ashleigh mendez ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497135359
• MDR Report Key: 21403636
• Report Number: 2027111-2025-00367
• Device Sequence Number: 9456054
• Product Code: GEI
• UDI-Device Identifier: 00607915138240
• UDI-Public: (01)00607915138240
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K202818
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: EB230
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/18/2025
• Supplement Report FDA Received Date: 04/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GENERATOR.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown