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

Model Number	EB214
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Codes	Adhesion(s) (1695); Hemorrhage/Blood Loss/Bleeding (1888); Laceration(s) (1946)
Date of Event	01/23/2026
Type of Reportable Event	Malfunction
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.
Event or Problem Description
Procedure performed: retroperitoneal mass.Event description: [hospital name] event description:"device using for sealing and cutting the tissues.", "during the operation, approximately 3 hours later, after an average of 200 activations, the jaws of the probe began to stick to the tissues.It was observed that the jaws tore the tissue directly by sticking to it.Furthermore, when the probe was placed on the table while not in use, the jaws stuck together even though the handle was open; nurses were able to open the jaws with warm isotonic water.During the procedure, nurses continuously cleaned the jaws (every 5-10 activations).After serious adhesions and bleeding were observed, the doctor could not continue the procedure with the probe and switched to [competitor device]." additional info received from field team member by email on 29 january 2026: there was a minor bleeding.Small bleedings.Closing letter needed.Patient status: good.Intervention: they opened [competitor device].

• 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: 24273389
• Report Number: 2027111-2026-00349
• Device Sequence Number: 13443211
• Product Code: GEI
• UDI-Device Identifier: 00607915140816
• UDI-Public: (01)00607915140816
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2026

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: EB214
• Device Catalogue Number: 101476828
• Device Lot Number: 1560075
• 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: 01/23/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/05/2026
• Supplement Report FDA Received Date: 05/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/11/2025
• 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
• Patient Sex: Unknown