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

Model Number	EB215
Medical Device Problem Code	Failure to Seal (4070)
Health Effect - Clinical Codes	Laceration(s) (1946); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: laparoscopic gastric sleeve event description: [hospital name] description received from the field team member on (b)(6) 2026: "the surgeon reported that while using the device intraoperatively, it unexpectedly stopped sealing tissue/vessels even though he was pressing the activation button and there was a sound from the generator; however, no sealing or cutting effect was achieved." description reported by sfda by email on february 25, 2026: "the device is designed to cauterize and cut at the same time; however, it neither cauterizes nor cuts." intervention: used another competitor device.Patient status: no injury or illness.
Additional Manufacturer Narrative
The event unit is not 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.Testing was performed on the event unit, which confirmed the complainant¿s experience of insufficient sealing.Based on the condition of the returned unit, it is likely that the reported event was due to the jaws being out of specification.Applied medical has performed a historical trend analysis and review of production records and no relevant documentation was identified.The event was initially reported based on the description of the event.However, based on the evaluation of the returned unit and further examination of the event description, applied medical determined that this event is not reportable as it is unlikely to lead to unanticipated death or unanticipated serious injury as the insufficient sealing was controlled through routine surgical procedure.Correction performed to section e2 to be yes.
Event or Problem Description
Procedure performed: laparoscopic gastric sleeve.Event description: [hospital name].Description received from the field team member on february 24, 2026: "the surgeon reported that while using the device intraoperatively, it unexpectedly stopped sealing tissue/vessels even though he was pressing the activation button and there was a sound from the generator; however, no sealing or cutting effect was achieved." description reported by sfda by email on february 25, 2026: "the device is designed to cauterize and cut at the same time; however, it neither cauterizes nor cuts." additional feedback received from the field team via email on march 09, 2026: "kindly note that i received the item from the hospital today." additional feedback received from the field team via email on march 11, 2026: "kindly note that i didn't receive any alarms." intervention: used another competitor device.Patient status: no injury or illness.

• 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: 24462431
• Report Number: 2027111-2026-00400
• Device Sequence Number: 15803494
• Product Code: GEI
• UDI-Device Identifier: 00607915139353
• UDI-Public: (01)00607915139353
• Combination Product (Y/N): N
• Initial Reporter Country: SA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2026

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: EB215
• Device Catalogue Number: 101477727
• Device Lot Number: 1530360
• 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: 02/23/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/26/2026
• Supplement Report FDA Received Date: 04/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/22/2024
• 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
• Patient Sex: Unknown