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

Model Number	EB215
Medical Device Problem Code	Self-Activation or Keying (1557)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: unknown.Event description: the event date is unknown.The contact person was not personally involved in the incident.Found the product on his desk when he returned from vacation with a handwritten note that the product had self-activated during use.The contact person did not know who was involved in the incident.He also did not know the date of the event, but would try to find this out.The product itself and the packaging for the instrument have been saved and can be sent back to applied for investigation.Patient status: no patient injury was indicated.Intervention: unknown.
Additional Manufacturer Narrative
The event unit is anticipated to return to applied medical for evaluation.A follow-up report will be sent upon completion of investigation.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Functional testing and visual inspection was performed on the event unit.However, the complainant¿s experience of unintended rf activation could not be replicated or confirmed as the event unit met current specifications.Applied medical has reviewed the details surrounding the event and related products and is unable to determine the cause of the reported event.Applied medical has performed a historical trend analysis and review of production records and no trends were identified.Correction performed to section e2 to update initial reporter information.
Event or Problem Description
Procedure performed: unknown.Event description: the event date is unknown.The contact person was not personally involved in the incident.Found the product on his desk when he returned from vacation with a handwritten note that the product had self-activated during use.The contact person did not know who was involved in the incident.He also did not know the date of the event but would try to find this out.The product itself and the packaging for the instrument have been saved and can be sent back to applied for investigation.Applied medical rep's response received via email on 2sep25: i have spoken to the contact person several times without him having further information regarding the case (he finds it very difficult to find out who was present during the incident as this happened while he was on holiday).Patient status: no patient injury was indicated.Intervention: unknown.

• Brand Name: VOYANT® MARYLAND 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: 22923889
• Report Number: 2027111-2025-00734
• Device Sequence Number: 13319602
• Product Code: GEI
• UDI-Device Identifier: 00607915139353
• UDI-Public: (01)00607915139353
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• PMA/510(K) Number: K200598
• 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): 11/18/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: EB215
• Device Catalogue Number: 101477727
• Device Lot Number: 1541404
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 08/04/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/29/2025
• Supplement Report FDA Received Date: 11/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/05/2024
• 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.
• Patient Sex: Unknown