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

Model Number	EB215
Medical Device Problem Code	Failure to Seal (4070)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit is anticipated to return to applied medial for evaluation.A follow-up report will be sent upon completion of the investigation.
Event or Problem Description
Procedure performed: laparoscopic salpingectomy.Event description: the doctor was performing a laparoscopic salpingectomy.The device was plugged in and the voyant generator said device ready.It made the sound of burning but no heat was applied to the tissue.When the dr cut the tissue he could see that no there was no burning of the tissue and it was bleeding.Information from distributor form: the device was plugged in and the voyant generator said device ready.It made the sound of burning but no heat was applied to the tissue.When the dr cut the tissue, he could see that no there was no burning of the tissue and it was bleeding.Additional information received by distributor via email on 10-mar-26: the bleeding was observed 1-2 seconds, 2 activations after the jaws were removed.The bleeding was removed using another voyant.The fallopian tubes were being sealed.The bleeding was not observed from a specific vessel seal.General oozing observed around a tissue bundle.No vascular pathology.Tension was applied, fallopian tubes were being held with a soft grasper.No eschar buildup.The jaws were not cleaned.No alarms.The "sound of burning" is the short peep peep peep sound the generator makes when it is sealing the tissue and then the long peeeeeeeep sound when the cycle is complete.Intervention: another device was opened and it worked better.Patient status: no clinical impact, just some bleeding.

• 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: 24613148
• Report Number: 2027111-2026-00441
• Device Sequence Number: 16008657
• Product Code: GEI
• UDI-Device Identifier: 00607915139353
• UDI-Public: (01)00607915139353
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2026

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: EB215
• Device Catalogue Number: 101476818
• Device Lot Number: 1554374
• 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: 03/02/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/16/2026
• Supplement Report FDA Received Date: 06/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/12/2025
• 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.; GRASPER.
• Patient Sex: Unknown