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

Model Number	EB210
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2026
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 the investigation.
Event or Problem Description
Procedure performed: supracervical hysterectomy + bilateral adnexectomy by laparoscopy event description: the voyant device, after being clamped, could not be reopened.After 5 mm of normal use, the surgeon was unable to reopen the voyant¿s jaws.Additional information was received by nca ref via email on 18feb2: user report was received with additional information: ai translation: the clamp jammed after 5 minutes of use and could not be opened despite several attempts.Use of this device for a supracervical hysterectomy + bilateral adnexectomy by laparoscopy.Patient status: no clinical impact to the patient.Intervention: they opened a new voyant device to complete the procedure.

• 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: 24576565
• Report Number: 2027111-2026-00437
• Device Sequence Number: 21140462
• Product Code: GEI
• UDI-Device Identifier: 00607915138424
• UDI-Public: (01)00607915138424
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2026

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: EB210
• Device Catalogue Number: 101476432
• Device Lot Number: 1543784
• 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: 02/10/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/11/2026
• Supplement Report FDA Received Date: 06/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/17/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: FENESTRATED LAPAROSCOPIC CLAMP.; GENERATOR.
• Patient Sex: Unknown