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	11/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: breast reduction and abd plastique event description: 2 products locked in the middle of surgery, not possible to use.Additional information received by applied medical rep via email on 20nov2025: lot number unknown.The jaws were locked in both closed and open position.No audible or visual damage noticed prior to the event.The jaws were unresponsive when the surgeon actuated the handle lever.The blade lever was not able return to position automatically.They had to use a pliers in one of the incidents to remove the device from the tissue.No tissue damage.No tissue bleeding.Intervention: device replacement patient status: successful procedures with new instruments.
Additional Manufacturer Narrative
The event unit is not returning to applied medical for evaluation.No lot information was provided.A follow-up report will be sent upon completion of investigation.
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
Procedure performed: breast reduction and abd plastique.Event description: 2 products locked in the middle of surgery, not possible to use.Additional information received by applied medical rep via email on 20nov25: lot number unknown.The jaws were locked in both closed and open position.No audible or visual damage noticed prior to the event.The jaws were unresponsive when the surgeon actuated the handle lever.The blade lever was not able return to position automatically.They had to use a pliers in one of the incidents to remove the device from the tissue.No tissue damage.No tissue bleeding.Intervention: device replacement.Patient status: successful procedures with new instruments.

• 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: 24401436
• Report Number: 2027111-2026-00386
• Device Sequence Number: 8158933
• Product Code: GEI
• UDI-Device Identifier: 00607915138455
• UDI-Public: (01)00607915138455
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2026

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
• 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: 11/13/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/20/2026
• Supplement Report FDA Received Date: 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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