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

Model Number	EB215
Medical Device Problem Codes	Energy Output Problem (1431); Output below Specifications (3004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: ni.Event description: ai translation: could you please send us a generator that is ready for use asap for tomorrow? we have a generator that is not working, and today we had to use the second one on site, but according to the operating room, it is not working properly.Tomorrow we need generators for several operations at the same time.[original french text].Additional information received from an applied medical representative via email on 17jun2025: there was no error message on the screen, end-of-activation sound and "ready" message on the generator even though the tissues had not fused at all.Serial number was confirmed [(b)(6)].At the beginning of the intervention, fusion was weak.Then there was no more fusion at all, even if no error message on the generator.Switching off the generator changed nothing.They tried to connect the clamp to another led generator and it fused, but only slightly.Tm was present with the healthcare user and it was stated by another surgeon he had the same problem last week with another eb215 handpiece [discarded], finding the fusion unsatisfactory but had not reported it.Type of intervention: used another manufacture handpiece.Patient status: no patient injury or illness was reported.
Additional Manufacturer Narrative
The event unit has returned to applied medical for evaluation.A follow-up report will be sent upon completion of the investigation.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Testing was performed on the event unit.However, the complainant¿s experience could not be replicated or confirmed as the event unit met current specifications.Applied medical has reviewed the details surrounding the event and related products and is unable to determine the cause of the reported event or confirm that a product malfunction occurred.Applied medical has performed a historical trend analysis and review of production records and no trends were identified.
Event or Problem Description
Procedure performed: ni.Event description: ai translation: could you please send us a generator that is ready for use asap for tomorrow? we have a generator that is not working, and today we had to use the second one on site, but according to the operating room, it is not working properly.Tomorrow we need generators for several operations at the same time.Original: pourriez-vous svp nous faire parvenir un générateur voyant de prêt en urgence pour demain ?nous avons un générateur qui ne fonctionne pas et aujourd¿hui nous avons dû nous servir du deuxième présent sur site, mais qui dixit le bloc opératoire ne fonctionnerait pas correctement.Demain nous avons besoin de générateurs pour plusieurs opérations en même temps.Additional information received from an applied medical representative via email on 17jun25: there was no error message on the screen, end-of-activation sound and "ready" message on the generator even though the tissues had not fused at all.Serial number was confirmed (b)(6).At the beginning of the intervention, fusion was weak.Then there was no more fusion at all, even if no error message on the generator.Switching off the generator changed nothing.They tried to connect the clamp to another led generator and it fused, but only slightly.Tm was present with the healthcare user and it was stated by another surgeon he had the same problem last week with another eb215 handpiece [discarded], finding the fusion unsatisfactory but had not reported it.Intervention: used another manufacture handpiece.Patient status: no patient injury or illness was reported.

• 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: 22689425
• Report Number: 2027111-2025-00678
• Device Sequence Number: 8912199
• Product Code: GEI
• UDI-Device Identifier: 00607915139353
• UDI-Public: (01)00607915139353
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2025

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: EB215
• Device Catalogue Number: 101477727
• Device Lot Number: 1537884
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2025
• 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: 06/17/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/01/2025
• Supplement Report FDA Received Date: 09/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/14/2024
• 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