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)
Date of Event	07/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit is anticipated to return to applied medical.A follow up report will be provided following the completion of the investigation.
Event or Problem Description
Procedure performed: laparoscopic left hemicolectomy.Event description: [hospital name].[distributor name].During the procedure, the eb210 handpiece functioned normally until midway the procedure, when it began releasing energy without the energy button being pressed.Additionally, the surgeon experienced delays when activating the energy fuse button, and in some instances, no energy was released.The generator displayed an ¿early button release¿ error.Consequently, the device was removed from the procedure, and the surgery continued using a [competitor device] blunt tip device.Fortunately, there were no patient complications resulting from this issue.Additional information provided on 18jul2025: the hospital purchased the device through [hospital name].Cannot tell you a number for how often the incident was observed, can say it wasn't a problem until midway the procedure.Yes, the ready message was displayed on the screen of the generator when the device was connected.Yes until midway the procedure, the activation tone had a delay when the fuse activation button was pressed, and energy was released without the button being pressed.The generator showed the early button release error.The generator was not turned off and on again while the hand device was plugged in.Patient status: no patient complications resulting from this issue; surgery completed, patient stable.Intervention: the device was removed from the procedure, and the surgery continued using a [competitor device] blunt tip device.
Event or Problem Description
Procedure performed: laparoscopic left hemicolectomy.Event description; [hospital name] [distributor name].During the procedure, the eb210 handpiece functioned normally until midway the procedure, when it began releasing energy without the energy button being pressed.Additionally, the surgeon experienced delays when activating the energy fuse button, and in some instances, no energy was released.The generator displayed an ¿early button release¿ error.Consequently, the device was removed from the procedure, and the surgery continued using a [competitor device] blunt tip device.Fortunately, there were no patient complications resulting from this issue.Additional information provided on 18jul2025: the hospital purchased the device through [hospital name].Can not tell you about a number for how often the incident was observed, can say it wasn't a problem until midway the procedure.Yes, the ready message was displayed on the screen of the generator when the device was connected.Yes, until midway the procedure, the activation tone had a delay when the fuse activation button was pressed, and energy was released without the button being pressed.The generator showed the early button release error.The generator was not turned off and on again while the hand device was plugged in.Patient status: no patient complications resulting from this issue; surgery completed, patient stable.Intervention: the device was removed from the procedure, and the surgery continued using a [competitor device] blunt tip device.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Functional testing was performed on the event unit, which confirmed the complainant¿s experience of unintended rf energy output.Based on the condition of the returned unit, it is likely that the reported event was caused by a misaligned fuse switch and spring.Applied medical has performed a historical trend analysis and review of production records and no relevant documentation was identified.

• 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: 22569992
• Report Number: 2027111-2025-00656
• Device Sequence Number: 3904236
• Product Code: GEI
• UDI-Device Identifier: 00607915138424
• UDI-Public: (01)00607915138424
• Combination Product (Y/N): N
• Initial Reporter State: PR
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2025

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: 07/06/2026
• Device Model Number: EB210
• Device Catalogue Number: 101475457
• Device Lot Number: 1495287
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/22/2025
• Supplement Report FDA Received Date: 10/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/07/2023
• 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
• Patient Sex: Unknown