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	05/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Type of procedure: laparoskopic hysterectomy.Event description: voyant maryland single step was used during a laparoscopic hysterectomy.After 90 activations the handle locked its selves.Jaws was unable to open and the knife was not able to be activated.Back bleeding from uterus was stopped by using bipolar grasper.Voyant was not used during this.Last time, before the event occurred, i saw the inner jaws was fine and clean.Additional information received from an applied medical representative via email on 30may25: the tm attended the surgery, no audio or visual damage.Yes, handle was unresponsive.I did try it too after it was off the patient.I assume that i would break the handle if i used more force.Blade was not responding when activating it.Blade was in neutral position.No, the jaws were not locked onto the tissue, the surgeon tried to reach tissue, but the handle was not responding.No tissue was damaged during the break down.This is the only one observed as i have attended to some 8 single step surgeries after this.Handle was not responding.I did ask the surgeon to close the handle and use the blade lever.Also releasing the handle ¿ nothing happened.As this was a trial i changed the handle with a new one from the shelves.Patient status: patient did not suffer any injuries due to the case.Intervention: device replacement.
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: laparoskopic hysterectomy.Event description: voyant maryland single step was used during a laparoscopic hysterectomy.After 90 activations the handle locked its selves.Jaws was unable to open and the knife was not able to be activated.Back bleeding from uterus was stopped by using bipolar grasper.Voyant was not used during this.Last time, before the event occurred i saw the inner jaws was fine and clean.Additional information received from an applied medical representative via email on 30may25: the tm attended the surgery; no audio or visual damage.Yes handle was unresponsive.I did try it too after it was off the patient.I assume that i would break the handle if i used more force.Blade was not responding when activating it.Blade was in neutral position.No the jaws were not locked onto the tissue, the surgeon tried to reach tissue, but the handle was not responding.No tissue was damaged during the break down.This is the only one observed as i have attended to some 8 single step surgeries after this.Handle was not responding.I did ask the surgeon to close the handle and use the blade lever.Also releasing the handle ¿ nothing happened.As this was a trial i changed the handle with a new one from the shelves.Patient status: patient did not suffer any injuries due to the case.Intervention: device replacement.
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 stopping the blade from fully returning.The instructions for use (ifu) states ¿buildup of eschar can negatively affect the device¿s sealing and cutting performance¿.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.Correction performed to update section h2.

• 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: 22136813
• Report Number: 2027111-2025-00565
• Device Sequence Number: 17998335
• Product Code: GEI
• UDI-Device Identifier: 00607915140793
• UDI-Public: (01)00607915140793
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K222284
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• 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): 08/06/2025

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: 05/13/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/03/2025
• Supplement Report FDA Received Date: 08/06/2025
• 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
• Patient Sex: Unknown