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

Model Number	EB215
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: vnote technique.Event description: when the dr latched the handle, it got stuck and wouldn¿t open again, dr [name] had to use both hands to open the handle back, so it got broken.Dr [name] could still continue the surgery with the handpiece, but he said it was broken and not latching properly.Additional information received via email on 25jan2024: we have reached out to the field team for further clarification, and they have informed us that the doctor can not recall any missing part tin the handpiece and he clarified that the handle broke and stopped latching accordingly.We have also checked if the missing piece fell into the patient, we were updated that the handpiece was used in a surgery which was conducted vaginally while using gelpoint v-path (vnote technique).Patient status: no patient impact intervention: doctor continue the surgery with the device.
Additional Manufacturer Narrative
The event unit has returned to applied medical.A follow up report will be provided upon completion of the investigation.
Event or Problem Description
Procedure performed: vnote technique.Event description: when the dr latched the handle, it got stuck and wouldn¿t open again, dr [name] had to use both hands to open the handle back, so it got broken.Dr [name] could still continue the surgery with the handpiece, but he said it was broken and not latching properly.Additional information received via email on 25jan2024: we have reached out to the field team for further clarification, and they have informed us that the doctor can not recall any missing part tin the handpiece and he clarified that the handle broke and stopped latching accordingly.We have also checked if the missing piece fell into the patient, we were updated that the handpiece was used in a surgery which was conducted vaginally while using gelpoint v-path (vnote technique) patient status: no patient impact.Intervention: doctor continue the surgery with the device.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Testing was performed on the event unit, which confirmed the customer¿s experience of jaws staying closed.Based on the condition of the returned unit, it is likely that the reported event was caused by a non-conforming trigger lock.Applied medical has performed a historical trend analysis and review of production records and no relevant documentation was identified.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.

• 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: 20916130
• Report Number: 2027111-2024-00952
• Device Sequence Number: 7846066
• Product Code: GEI
• UDI-Device Identifier: 00607915139353
• UDI-Public: (01)00607915139353
• Combination Product (Y/N): N
• Initial Reporter Country: LE
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2025

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 Expiration Date: 04/04/2025
• Device Model Number: EB215
• Device Catalogue Number: 101475463
• Device Lot Number: 1449487
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2023
• 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: 11/13/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/12/2024
• Supplement Report FDA Received Date: 01/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/05/2022
• 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: C2A12.
• Patient Sex: Unknown