MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES VOYANT MARYLAND FUSION DEVICE WITH SINGLE-STEP ACTIVATION; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	EB212
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2025
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
Type of procedure: hysterectomy v-notes.Event description: i was sealing the uterine parametria.The doctor had made about 20 seals when, after the last activation, the blade got stuck inside the jaws and the jaws could neither open nor close.The blade was locked and the jaws were locked as well.No harm to the patient.Voyant did the last activation correctly and then stopped opening the jaw to be able to continue using it.They opened a [competitor device] and continued with the surgery.Additional information received by applied medical rep via email on 20may2025: the batch number is correct.It's a pincer that i had ordered in order to be able to test the product.It sounded like a strange noise that it wasn't known where it was coming from.No vascular pathology.In fact the surgeon did not complain at any time.When it got stuck, it was definitive.The jaw got stuck with the blade halfway through.Additional information received from an applied medical representative via email on 27may2025: the jaws were locked closed and the jaws were not locked around the tissue; it coagulated, cut and released from the tissue.But the jaws remained locked.They opened another clamp, [brand redacted] 37cm.Patient status: perfect.Well.Intervention: opened one [competitor device] and continued with the surgery.
Event or Problem Description
Type of procedure: hysterectomy v-notes.Event description: i was sealing the uterine parametria.The doctor had made about 20 seals when, after the last activation, the blade got stuck inside the jaws and the jaws could neither open nor close.The blade was locked and the jaws were locked as well.No harm to the patient.Voyant did the last activation correctly and then stopped opening the jaw to be able to continue using it.They opened a [competitor device] and continued with the surgery.Additional information received by applied medical rep via email on 20may25: the batch number is correct.It's a pincer that i had ordered in order to be able to test the product.It sounded like a strange noise that it wasn't known where it was coming from.No vascular pathology.In fact the surgeon did not complain at any time.When it got stuck, it was definitive.The jaw got stuck with the blade halfway through.Additional information received from an applied medical representative via email on 27may25: the jaws were locked closed and the jaws were not locked around the tissue; it coagulated, cut and released from the tissue.But the jaws remained locked.They opened another clamp, [brand redacted] 37cm.Patient status: perfect.Well.Intervention: opened one [competitor device] and continued with the surgery.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Testing was performed on the event unit, which confirmed a stuck blade.This confirms the complainant¿s experience of jaws staying closed.Based on the evaluation of the event unit and the description of the event, it is likely that the reported event was caused by the eschar build up within the blade channel, which prevented the blade from fully returning.Applied medical has performed a historical trend analysis and review of production records and no trends were identified.This event was initially reported based on the description of the event.However, based on the evaluation of the returned unit, applied medical determined that this event is not reportable as it is unlikely to cause or contribute to death or serious injury.

• Brand Name: VOYANT MARYLAND FUSION DEVICE WITH SINGLE-STEP ACTIVATION
• 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: 22207352
• Report Number: 2027111-2025-00591
• Device Sequence Number: 15370549
• Product Code: GEI
• UDI-Device Identifier: 00607915140793
• UDI-Public: (01)00607915140793
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K222284
• 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): 08/11/2025

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 Model Number: EB212
• Device Catalogue Number: 101476821
• Device Lot Number: 1544095
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 05/15/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/13/2025
• Supplement Report FDA Received Date: 08/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/19/2024
• 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; MONOPOLAR POWER CLAMP
• Patient Sex: Unknown