MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES VOYANT® 5MM FUSION DEVICE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	EB210
Medical Device Problem Code	Self-Activation or Keying (1557)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2025
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 following the completion of the investigation.
Event or Problem Description
Type of procedure: otb (bilateral tubal occlusion).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.[doctor], 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 energy button, the console immediately made a sound without delivering the energy.There was no impact on the patient the patient is stable and there were no consequences.Patient status: the patient is stable and there were no consequences intervention: they gave the doctor another "clamp".
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Testing was performed on the event unit.However, the complainant¿s experience could not be replicated or confirmed as the event unit met current specifications.Applied medical has reviewed the details surrounding the event and related products and is unable to determine the cause of the reported event or confirm that a product malfunction occurred.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: otb (bilateral tubal occlusion).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.[doctor] 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 energy button, the console immediately made a sound without delivering the energy.There was no impact on the patient.The patient is stable and there were no consequences.Patient status: the patient is stable and there were no consequences.Intervention: they gave the doctor another "clamp".

• Brand Name: VOYANT® 5MM 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: 22110344
• Report Number: 2027111-2025-00558
• Device Sequence Number: 15512043
• Product Code: GEI
• UDI-Device Identifier: 00607915138424
• UDI-Public: (01)00607915138424
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K201212
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2025

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: 06/16/2025
• Device Model Number: EB210
• Device Catalogue Number: 101476661
• Device Lot Number: 1457677
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/29/2025
• Supplement Report FDA Received Date: 08/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/17/2022
• 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 TROCARS; TWO 5MM ADVANCED FIXATION TROCAR
• Patient Sex: Unknown