MAUDE Adverse Event Report: Applied Medical Resources VOYANT® Maryland Fusion Device; Electrosurgical, Cutting & Coagulation & Accessories

Model Number	EB216
Medical Device Problem Code	Failure to Seal (4070)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	07/06/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Procedure performed: laparoscopic gastric sleeve.Event description: device failed to seal and caused bleeding.Almost had to switch patient to open surgery.Post-procedure, hemoglobin levels were low, so the patient received a blood transfusion.Information provided on (b)(6) 2026: remaining sterile units from lot #1585275 will be returning.Rep will update on quantity.Patient status: stable.Intervention: ni.

• 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 ; +1(949)713-5359
• MDR Report Key: 50215831
• Report Number: 2027111-2026-00681
• Device Sequence Number: 17666927
• Product Code: GEI
• UDI-Device Identifier: 00607915139360
• UDI-Public: (01)00607915139360
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/11/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: EB216
• Device Catalogue Number: 101479201
• Device Lot Number: 1585275
• Was Device Available for Evaluation?: No
• 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: 07/13/2026
• Initial Report FDA Received Date: 08/11/2026
• Date Device Manufactured: 03/17/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown