MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES VOYANT MARYLAND FUSION DEVICE WITH SINGLE-STEP ACTIVATION; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	EB212
Medical Device Problem Codes	Self-Activation or Keying (1557); Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: adrenalectomy lap event description: he was working normally, picking and sealing tissue.When activating the blade, it did not cut the tissue correctly and when repeatedly activating it to cut, the sealing alarm was activated by mistake.Patient status: correct.Intervention: device replacement.
Additional Manufacturer Narrative
The event unit is not anticipated to returned to applied medical.A follow up report will be provided following the completion of the investigation.
Event or Problem Description
Procedure performed: adrenalectomy lap.Event description: he was working normally, picking and sealing tissue.When activating the blade, it did not cut the tissue correctly and when repeatedly activating it to cut, the sealing alarm was activated by mistake.Additional information received by applied medical rep via email on 27jun25: no pushing of the tissue instead of being cut.No audible or visual damage prior to the incident.It does not cut well from the beginning and gradually gets worse and worse.No resistance or difficulty when actuating the blade lever.Perirenal fat and adjacent tissues no particular vascular pathology.No cold cut.No attempt to cut over sutures, staple lines, or other objects.It didn't cut well in general in all parts.Sometimes 20%, sometimes 50%, sometimes 100% of the tissue was cut.It cut badly from the beginning of the surgery, but little by little it cut worse.Finished the surgery with another device as this one ended up not working properly.Very little improvement when the jaws were cleaned.Patient status: correct.Investigation: device replacement.
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.This event was initially reported based on the description of the event.However, based on further examination of the event description, applied medical determined that this event is not reportable as it is unlikely to lead to death or serious deterioration in the state of health.

• Brand Name: VOYANT MARYLAND FUSION DEVICE WITH SINGLE-STEP ACTIVATION
• 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: 22333018
• Report Number: 2027111-2025-00605
• Device Sequence Number: 21113654
• Product Code: GEI
• UDI-Device Identifier: 00607915140793
• UDI-Public: (01)00607915140793
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K222284
• 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): 08/22/2025

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: EB212
• Device Catalogue Number: 101476821
• Device Lot Number: 1544095
• 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: 06/03/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/25/2025
• Supplement Report FDA Received Date: 08/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/19/2024
• 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; GRASPER
• Patient Sex: Unknown