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 Codes	Self-Activation or Keying (1557); Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2025
Type of Reportable Event	Malfunction
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
Procedure performed: lap lymphadenotomy, hysterectomy, adnexectomy event description: sterile item from tm scrub stock for evaluation normal applications and sealing during procedure.When closing the instrument a loud cracking was heard.Afterwards there was no resistance when the instrument was closed.The instrument did not open automatically anymore.Additional information received by applied medical rep via email on 20jun25: the rep brought the instrument to the or from his personal scrub stock.It did not lock.The loud cracking happened during normal use.Jaw still moves but there is no "grasping zone" anymore and does not open automatically anymore.No audible or visual damage prior to the incident.Approx.50 times (lymphadectomy finished, adnexectomy on one side, hysterectomy started).There was no thick or tense tissue.There were some accidentally short activations because the surgeon was used to press the handle to open it with eb215 and did accidentally so with the new single step eb212.No lock, no tissue damage or bleeding.The blade lever was able to spring back into position/return to position automatically.Patient status: good intervention: instrument replaced with normal voyant maryland (eb215).

• 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: 22363780
• Report Number: 2027111-2025-00620
• Device Sequence Number: 18214946
• Product Code: GEI
• UDI-Device Identifier: 00607915140793
• UDI-Public: (01)00607915140793
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K222284
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2026

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: 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: 06/13/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/30/2025
• Supplement Report FDA Received Date: 05/27/2026
• 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