MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES VOYANT® ELECTROSURGICAL GENERATOR; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	EA020
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Sparking (2595); Electrical Shorting (2926)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2025
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 sent upon completion of the investigation.
Event or Problem Description
Procedure performed: n/a (before the procedure).Event description: "the device was brought into the room before surgery.The event occurred when it was plugged in for a functionality check.When the device¿s power cable is plugged into the socket, it immediately causes a short circuit and trips the circuit breaker.The issue persists even after testing with different power cables and sockets, indicating that the problem is likely internal to the device." intervention: a new device has been installed at the hospital.Patient status: n/a.

• Brand Name: VOYANT® ELECTROSURGICAL GENERATOR
• 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: 24191543
• Report Number: 2027111-2026-00340
• Device Sequence Number: 9513442
• Product Code: GEI
• UDI-Device Identifier: 00607915137601
• UDI-Public: (01)00607915137601
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K182244
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2026

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: EA020
• Device Catalogue Number: 101470971
• Device Lot Number: 1367453
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2025
• 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: 01/06/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/27/2026
• Supplement Report FDA Received Date: 06/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/28/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown