MAUDE Adverse Event Report: Applied Medical Resources Voyant Open Fusion Device; Electrosurgical, Cutting & Coagulation & Accessories

Model Number	EB240
Medical Device Problem Code	Excessive Heating (4030)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: open cystectomy + small bowel obstruction.Event description: "[name]" (b)(6) was present as was attending cases in adelaide helping out.The gynecologist was sealing consecutively around an ovarian trying to mobilize it and then he placed it down on top of a drape and the plastic jaws burnt a hole through the sterile drape.No issue recorded as they continued using the device and it was sealing well.After the case the colorectal surgeon who was present was unhappy with the amount of thermal spread the device put out.No clinical impact to the patient.They continued using the device and didn't raise the situation as a fault but rather as the devices feature overall.Additional information received from "[name]" (snr territory manager) via email on 23july26: when the jaws burnt through the drapes, everyone in the room just contributed it consecutive sealing without letting the jaws cool down.In future when the device was put down it was then laid over a wet sponge to prevent it from happening again.Intervention: continued on.Patient status: not affected.
Additional Manufacturer Narrative
The event unit is not returning to applied medical for evaluation.A follow-up report will be submitted upon completion of investigation.

• Brand Name: Voyant Open 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 ; +1(949)713-5359
• MDR Report Key: 50010776
• Report Number: 2027111-2026-00665
• Device Sequence Number: 20281432
• Product Code: GEI
• UDI-Device Identifier: 00607915138455
• UDI-Public: (01)00607915138455
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K252740
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/23/2026

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: EB240
• Device Catalogue Number: 101473830
• Device Lot Number: 1590155
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2026
• Initial Report FDA Received Date: 07/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/01/2026
• 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: Alexis
• Patient Sex: Unknown