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	02/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit is not returning to applied medical.A follow-up report will be provided following the completion of the investigation.
Event or Problem Description
Type of procedure: hysterotomy.Event description: the energy was supposed to be activated, but the clamp was supplying energy on its own without the doctor pressing the button to activate it.Dr.[name], a gynecologist, already has experience with the clamp and noticed that the energy was activating by itself without pressing the button.When he tried to press the button, he couldn't.Advanced fixation trocar, two of 12 mm and two of 5 mm.They gave the doctor another clamp.Patient status: there was no impact on the patient.Intervention: they gave the doctor another clamp.
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 relevant documentation was identified.
Event or Problem Description
Type of procedure: histeroctomy.Event description: the energy was supposed to be activated, but the clamp was supplying energy on its own without the doctor pressing the button to activate it.Dr.[name], a gynecologist, already has experience with the clamp and noticed that the energy was activating by itself without pressing the button.When he tried to press the button, he couldn't.Advanced fixation trocar, two of 12 mm and two of 5 mm.They gave the doctor another clamp.Patient status: there was no impact on the patient.Intervention: they gave the doctor another clamp.

• 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: 21428823
• Report Number: 2027111-2025-00376
• Device Sequence Number: 14543082
• Product Code: GEI
• UDI-Device Identifier: 00607915139353
• UDI-Public: (01)00607915139353
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2025

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 Expiration Date: 07/27/2025
• Device Model Number: EB215
• Device Catalogue Number: 101476665
• Device Lot Number: 1460069
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/20/2025
• Supplement Report FDA Received Date: 06/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/28/2022
• 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: TWO 12MM ADVANCED FIXATION TROCAR.; TWO 5MM ADVANCED FIXATION TROCAR.
• Patient Sex: Unknown