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

Model Number	EB215
Medical Device Problem Code	Self-Activation or Keying (1557)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2025
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
Type of procedure performed: vnotes hysterectomy.Event description: after about 10 minutes use of voyant during the laparoscopic phase.Voyant started to malfunction.Did not activate when energy button was pushed.Instead activated when latching handle was compressed.Undocked the voyant device key but did not work.Restarted the generator.Did not work.Replaced the handpiece with a new eb215.Additional information received by applied medical rep via email on 18jun2025: lot number on the kit gk770 (this is a eb215 that was included in the kit) is: 1557878.Lot number on the voyant is: 1543385.They heard the activation and end tone.The surgeon activated the blade after the end tone.There was no bleeding from the incident.Patient status: patient is well.No harm done by incident.Intervention: device replacement.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Testing was performed on the event unit, which confirmed the complainant¿s experience of unintended rf energy output.Based on the condition of the returned unit, it is likely that the reported event was caused by a misaligned fuse switch.Applied medical has performed a historical trend analysis and review of production records and no relevant documentation was identified.
Event or Problem Description
Procedure performed: vnotes hysterectomy event description: after about 10 minutes use of voyant during the laparoscopic phase.Voyant started to malfunction.Did not activate when energy button was pushed.Instead activated when latching handle was compressed.Undocked the voyant device key, but did not work.Restarted the generator.Did not work.Replaced the handpiece with a new eb215.Additional information received by applied medical rep via email on 18jun25: lot number on the kit gk770 (this is a eb215 that was included in the kit) is: 1557878.Lot number on the voyant is: 1543385.They heard the activation and end tone.The surgeon activated the blade after the end tone.There was no bleeding from the incident.Intervention: device replacement patent status: patient is well.No harm done by incident.

• 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: 22385942
• Report Number: 2027111-2025-00623
• Device Sequence Number: 12507254
• Product Code: GEI
• UDI-Device Identifier: 00607915139353
• UDI-Public: (01)00607915139353
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2025

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: 1543385
• 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: 06/04/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/02/2025
• Supplement Report FDA Received Date: 09/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/06/2025
• 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: FORCEPS.; GELPOINT VPATH C2A12.; GENERATOR.
• Patient Sex: Unknown