MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES VOYANT MARYLAND FUSION DEVICE WITH SINGLE-STEP ACTIVATION; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	EB213
Medical Device Problem Codes	Self-Activation or Keying (1557); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: gastric sleeve case.Event description: the generator displayed an error code that said, "stuck button." additional information obtained from account manager via email on 09apr2025: the hand piece was plugged in and when they went to use it in the first activation, the generator said button stuck and they could not release the device jaws.So, they used and opened another one.They have not seen this happen before.Additional information obtained from account manager via email on 09apr2025: the generator was not turned off and on again.They heard the tone as usual and went to use it and got the error and it would not work.It was a gastric sleeve case.Intervention: opened another device.Patient status: patient is fine.
Additional Manufacturer Narrative
The event unit will not be returning to applied medical for evaluation, but a lot number was provided.A follow-up report will be submitted upon completion of investigation.
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.As the event unit was not returned, applied medical is unable to determine if the event unit exhibited any non-conformances that could have contributed to the reported event.In the absence of the event unit, it is difficult to determine if the reported event was caused by a manufacturing non-conformance or circumstantial factors at the time of use.Applied medical has reviewed the details surrounding the event and is unable to determine the exact root cause of the event.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: gastric sleeve case.Event description: the generator displayed an error code that said "stuck button." additional information obtained from account manager via email on 09apr2025: the hand piece was plugged in and when they went to use it in the first activation, the generator said button stuck and they could not release the device jaws.So they used and opened another one.They have not seen this happen before.Additional information obtained from account manager via email on 09apr2025: the generator was not turned off and on again.They heard the tone as usual and went to use it and got the error and it would not work.It was a gastric sleeve case.Intervention: opened another device patient status: patient is fine.

• 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: 21929020
• Report Number: 2027111-2025-00498
• Device Sequence Number: 9096250
• Product Code: GEI
• UDI-Device Identifier: 00607915140809
• UDI-Public: (01)00607915140809
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2025

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: EB213
• Device Catalogue Number: 101477724
• Device Lot Number: 1530357
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/29/2025
• Supplement Report FDA Received Date: 07/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/22/2024
• 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
• Patient Sex: Unknown