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)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit will not be returning to applied medical.A follow-up report will be provided following the completion of the investigation.
Event or Problem Description
Type of procedure: ni event description: name: voyant 5 mm fusión reference: eb210 serial: (b)(6).Description event: they are performing the action of checking that the sealing button is attached, but it is perceived as normal.The doctor presses the sealing button again.However, the alarm remains active, and the claw does not seal.The patient is bleeding.As a result, it was necessary to use another claw to complete the surgical procedure.Sample available: no patient status: no patient injury reported as a result of this event.Intervention: it was necessary to use another claw to complete the surgical procedure.
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: total hysterectomy plus salpingectomy by laparoscopy event description: name: voyant 5 mm fusión.Reference: eb210.Serial: (b)(6).Description event: they are performing the action of checking that the sealing button is attached, but it is perceived as normal.The doctor presses the sealing button again.However, the alarm remains active, and the claw does not seal.The patient is bleeding.As a result, it was necessary to use another claw to complete the surgical procedure.Sample available: no.Additional information provided on 27feb2025 via email: no patient injury occurred.Patient stable, procedure finished successfully.Event date was 05feb2025.Procedure was total hysterectomy plus salpingectomy by laparoscopy.Monopolar and conventional bipolar devices used as well.The hand device was discarded.Utero-ovarian ligament was being grasped when the incident was observed.The patient did not exhibit any vascular pathology, and the device was not activated on diseased or inflamed tissue.The issue was observed since the procedure started the instrument never worked.A liquid or lubricant solution was not applied to the jaws or tissue during the case.From the beginning of its use, it did not work; it was tested with approximately 10 activations.The clamp ultimately did not work, and the solution was to discard it, retrieve a new clamp, and use it to perform the procedure.Patient status: patient stable, procedure finished successfully.Intervention: it was necessary to use another claw to complete the surgical 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: 21412338
• Report Number: 2027111-2025-00369
• Device Sequence Number: 15584474
• Product Code: GEI
• UDI-Device Identifier: 00607915138424
• UDI-Public: (01)00607915138424
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2025

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 Expiration Date: 02/08/2025
• Device Model Number: EB210
• Device Catalogue Number: 101475457
• Device Lot Number: 1443666
• Was Device Available for Evaluation?: No
• 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: 02/12/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/19/2025
• Supplement Report FDA Received Date: 06/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/09/2022
• 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: GENERATOR; MONOPOLAR AND CONVENTIONAL BIPOLAR
• Patient Sex: Unknown