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

Model Number	EB215
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: vnotes hysterectomy- event description: the device locked up during the procedure.The blade lever got stuck and it wasn't able to open again.It locked in a closed position.The account manager, was present in the case.Additional information provided by [account manager]: surgeon was cutting around round ligament of uterus.No vascular pathology was exhibited, and tissue did not appear diseased or inflamed.The blade only became stuck once when the jaws were unable to open again.Device had been used for approximately 15 minutes and 15-20 activations.The jaws were not cleaned before becoming stuck.The jaws were not cleaned.The account is requesting a replacement.No charge po# pending.Additional information provided by 03oct2025: the jaws were not locked onto tissue, after applying energy and transecting the tissue the jaws did not reopen.The issue was not able to be resolved, and the device had to be replaced.Additional information obtained from account manager via email on 13oct2025: 1.Can you please verify if removing the jaw from the tissue resulted in any damage? removing the jaws did not cause damage to any tissue.2.How were they able to remove the device from tissue after transecting if the jaws stayed closed? the doctor released the handle before letting go of the blade lever resulting in the jaws slightly opening.This allowed the device to be removed but unable to re-open enough to continue the case with the hand piece.I'm under the impression the technique of letting the handle go before the blade lever is viable with the [competitor] but not voyant.Moving forward i will educate doctors using voyant of this technique.Please let me know if there is any more information i can provide.Intervention: they grabbed another handpiece.Patient status: fine.
Additional Manufacturer Narrative
The event unit is anticipated to return to applied medical for evaluation.A follow-up report will be sent upon completion of investigation.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Testing was performed on the event unit, where the complainant¿s experience of jaws staying closed was confirmed.Based on the evaluation of the event unit and the description of the event, it is likely that the reported event was caused by a bent and broken blade.Applied medical has performed a historical trend analysis and review of production records and no relevant documentation was identified.This event was initially reported based on the description of the event.However, based on further examination of the event description and 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.Corrected section d10, updated for gel v path to listed as the concomitant device.
Event or Problem Description
Procedure performed: vnotes hysterectomy.Event description: the device locked up during the procedure.The blade lever got stuck and it wasn't able to open again.It locked in a closed position.The account manager, was present in the case.Additional information provided by [account manager]: surgeon was cutting around round ligament of uterus.No vascular pathology was exhibited, and tissue did not appear diseased or inflamed.The blade only became stuck once when the jaws were unable to open again.Device had been used for approximately 15 minutes and 15-20 activations.The jaws were not cleaned before becoming stuck.The jaws were not cleaned.The account is requesting a replacement.No charge po# pending.Additional information provided by 03oct2025: the jaws were not locked onto tissue, after applying energy and transecting the tissue the jaws did not reopen.The issue was not able to be resolved, and the device had to be replaced.Additional information obtained from account manager via email on 13oct2025: 1.Can you please verify if removing the jaw from the tissue resulted in any damage? removing the jaws did not cause damage to any tissue.2.How were they able to remove the device from tissue after transecting if the jaws stayed closed? the doctor released the handle before letting go of the blade lever resulting in the jaws slightly opening.This allowed the device to be removed but unable to re-open enough to continue the case with the hand piece.I'm under the impression the technique of letting the handle go before the blade lever is viable with the [competitor] but not voyant.Moving forward i will educate doctors using voyant of this technique.Please let me know if there is any more information i can provide.Intervention: they grabbed another handpiece.Patient status: fine.

• Brand Name: VOYANT® MARYLAND 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: 23353115
• Report Number: 2027111-2025-00815
• Device Sequence Number: 13016590
• Product Code: GEI
• UDI-Device Identifier: 00607915139353
• UDI-Public: (01)00607915139353
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K200598
• 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): 01/21/2026

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 Expiration Date: 05/04/2026
• Device Model Number: EB215
• Device Catalogue Number: 101475463
• Device Lot Number: 1486762
• 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: 09/29/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/21/2025
• Supplement Report FDA Received Date: 01/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: GEL V PATH; GENERATOR
• Patient Sex: Unknown