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

Model Number	EB240
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit has been returned to applied medical for evaluation.A follow-up report will be submitted upon completion of investigation.
Event or Problem Description
Procedure performed: abdominoplasty.Event description: device was used for abdominoplasty procedure.User has been using for several years and it is a common procedure at this account.No known lot or serial number due to not registered during procedure and packaging thrown away.2 eb240 devices were used during the procedure as described below.The operation started and went smoothly until the excess was to be removed, when the lever that divides the tissue (blade lever & knife) got stuck and could not be moved.A new one (eb240 device) is brought up and we continue to burn and cut until the same thing happens again.We can open the jaws now and we continue to use the voyant to only seal vessels, not cut.The operation is completed without any problems.Noted by surgeon and or nurse was that the patient has a harder fat layer and many strong vessels.Intervention: they brought out another device as described above.New device worked in the beginning and then the same result except that with the second device they could reopen the jaws.They continued using the device as a sealing device only without cutting.Patient status: no harm to patient.

• 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 ; 9497135359
• MDR Report Key: 24851927
• Report Number: 2027111-2026-00482
• Device Sequence Number: 15685022
• Product Code: GEI
• UDI-Device Identifier: 00607915138455
• UDI-Public: (01)00607915138455
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2026

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: 101474398
• Device Lot Number: 1548912
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2026
• 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: 03/17/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/11/2026
• Supplement Report FDA Received Date: 05/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/12/2025
• 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: GENERATOR.
• Patient Sex: Unknown