MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES VOYANT® 5MM FUSION DEVICE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	EB210
Medical Device Problem Code	Self-Activation or Keying (1557)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	08/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event units is anticipated to return to applied medical for evaluation.A follow-up report will be sent upon competition of investigation.
Event or Problem Description
Procedure performed: lap anterior resection.Event description: during the start of the case, bowel was being mobilized for resection.Surgeon had already completed a few activations, removed handpiece from patient.As he was placing to back in the patient the handpiece started activating without the depression of the button.Removed form patient immediately.Thought maybe the button was stuck so pressed it a couple times to release button.Handpiece worked as usually for another 3 or so activations but as they were about the take the ima the handpiece started activation again without button depression.Removed immediately.Generator was beeping, alrey coed was not recorded.Not used again.Clinical impact to the patient: yes, some patient tissue was burnt on the connective tissue.Nil critical harm.15.08.2025 additional information received from [territory manager] via email: so sorry that was supposed to say, ¿alert code¿ was not recorded.Patient status: stable.Intervention: used ligasure.
Event or Problem Description
Procedure performed: lap anterior rescection.Event description: during the start of the case, bowel was being mobilized for resection.Surgeon had already completed a few activations, removed handpiece from patient.As he was placing to back in the patient the handpiece started activating without the depression of the button.Removed form patient immediately.Thought maybe the button was stuck so pressed it a couple times to release button.Handpiece worked as usually for another 3 or so activations but as they were about the take the ima the handpiece started activation again without button depression.Removed immediately.Generator was beeping, alrey coed was not recored.Not used again.Clinical impact to the patient: yes, some patient tissue was burnt on the connective tissue.Nil critical harm.15.08.2025 additional information received from [territory manager] via email: so sorry that was supposed to say, ¿alert code¿ was not recorded.Patient status: stable.Intervention: used [competitor device].
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Testing was performed on the event unit, which confirmed the complainant¿s experience of unintended rf output.Based on the condition of the returned unit it is likely that the reported event was caused by a misaligned fuse switch.Applied medical has performed a historical trend analysis and review of production records and no relevant documentation was identified.

• Brand Name: VOYANT® 5MM 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: 22842723
• Report Number: 2027111-2025-00704
• Device Sequence Number: 17369151
• Product Code: GEI
• UDI-Device Identifier: 00607915138424
• UDI-Public: (01)00607915138424
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K201212
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: EB210
• Device Catalogue Number: 101475457
• Device Lot Number: 1544405
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/19/2025
• Supplement Report FDA Received Date: 11/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/12/2025
• 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: GRASPERS.; TROCARS.
• Patient Sex: Unknown