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)
Date of Event	04/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit is anticipated to return to applied medical.A follow-up report will be provided upon completion of the investigation.
Event or Problem Description
Procedure performed: gastric sleeve.Event description: the voyant instrument did not start sealing immediately, but often only after the activation button had been pressed two or three times.On two occasions observed, the device started sealing without touching the activation button (fortunately freely in the abdominal cavity) when the jaws were open.After that, the customer decided to change the instrument and could finish the surgery with the new instrument without malfunction.Intervention: device replacement.Patient status: no harm to the patient.
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.
Event or Problem Description
Procedure performed: gastric sleeve event description: the voyant instrument did not start sealing immediately, but often only after the activation button had been pressed two or three times.On two occasions observed, the device started sealing without touching the activation button (fortunately freely in the abdominal cavity) when the jaws were open.After that, the customer decided to change the instrument and could finish the surgery with the new instrument without malfunction.Patient status: no harm to the patient.Intervention: device replacement.

• 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: 22099338
• Report Number: 2027111-2025-00555
• Device Sequence Number: 8340348
• Product Code: GEI
• UDI-Device Identifier: 00607915139353
• UDI-Public: (01)00607915139353
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 08/26/2025

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: 1537884
• 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: 04/28/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/28/2025
• Supplement Report FDA Received Date: 08/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/14/2024
• 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