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

Model Number	EB230
Medical Device Problem Codes	Patient Device Interaction Problem (4001); Excessive Heating (4030)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	12/02/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Procedure performed: left parotidectomy -totally 57 activations.Event description: during a left parotidectomy procedure performed on (b)(6) 2024, for [age redacted] patient, the voyant fine fusion device was utilized, at the conclusion of the procedure, just before closing the skin, a small 1 cm skin burn was observed on the patient, the cause of the burn remains unclear, all procedural steps were consistent with those followed in similar cases, with the only notable difference being the use of the voyant device.On the day the consultants were not sure what caused the burn.When re visiting on (b)(6) and speaking with the consultants again, there was a concern that the only differing factor was the voyant system, but they still have no clue what caused it.From my observations in the procedures, the jaws did not touch the skin.-all surgeons used again on (b)(6) pm for their thyroidectomy case and had no issues.Additional information received from company rep.Via email on (b)(6) 2025: lot number of the device 1531819, 1 (left parotidectomy) -totally 57 activations.The skin burn was trimmed over the edge using a scalpel, and two sutures were placed for closure.Standard ent instrument sets.Type of intervention: the skin burn was trimmed over the edge using a scalpel, and two sutures were placed for closure patient status: a small 1 cm skin burn was observed on the patient.
Additional Manufacturer Narrative
The event unit is not returning to applied medical for evaluation.A follow-up report will be submitted upon completion of investigation.
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-conformance's 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 documentations were identified.
Event or Problem Description
Procedure performed: left parotidectomy -totally 57 activations.Event description: during a left parotidectomy procedure performed on (b)(6) 2024, for [age redacted] patient, the voyant fine fusion device was utilized, at the conclusion of the procedure, just before closing the skin, a small 1 cm skin burn was observed on the patient, the cause of the burn remains unclear, all procedural steps were consistent with those followed in similar cases, with the only notable difference being the use of the voyant device.On the day the consultants were not sure what caused the burn.When re visiting on (b)(6) and speaking with the consultants again, there was a concern that the only differing factor was the voyant system, but they still have no clue what caused it.From my observations in the procedures, the jaws did not touch the skin.All surgeons used again on (b)(6) pm for their thyroidectomy case and had no issues.Additional information received from company rep.Via email on 03jan2025: lot number of the device 1531819, 1 (left parotidectomy) -totally 57 activations.The skin burn was trimmed over the edge using a scalpel, and two sutures were placed for closure.Standard ent instrument sets.Type of intervention: the skin burn was trimmed over the edge using a scalpel, and two sutures were placed for closure patient status: a small 1 cm skin burn was observed on the patient.

• 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: 21087451
• Report Number: 2027111-2025-00306
• Device Sequence Number: 17867160
• Product Code: GEI
• UDI-Device Identifier: 00607915138240
• UDI-Public: (01)00607915138240
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2025

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
• Device Catalogue Number: 101476431
• Device Lot Number: 1531819
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/06/2025
• Supplement Report FDA Received Date: 01/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/06/2024
• 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.; STANDARD ENT INSTRUMENT SETS.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown