MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES VOYANT® 5MM FUSION DEVICE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	EB210
Medical Device Problem Code	Energy Output Problem (1431)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit is anticipated to return to applied medical for evaluation.A follow-up report will be submitted upon completion of investigation.
Event or Problem Description
Procedure performed: ap resection.Event description: used laparoscopically around the mesorectum on an ap resection.Small vessels as major vessels transected using a stapler small vessels in mesorectum being divided and not sealing at all.No alarm to alert and hence bleeding ensued.The device key had been discarded, so wont be returned for analysis.No clinical impact to patient.17.11.2025 additional information received from territory manager via email.Just in case you hadn't noticed, but the first three questions were answered in the original report.Ap resection.But unaware how the case proceeded or whatever else they used as i wasn't present.And so, the last question, i can't answer and i'm unsure whether the surgeon would have noticed the activation tone or not.18.11.2025 additional information received from territory manager via email in response to requested information "when the fuse button was pressed, did you notice the start tone or an ¿activating¿ message on the generator, or did the generator continue to show ¿ready¿ without any apparent activity? response: there was an activation tone but no alarm intervention: unsure about what else was used.Patient status: ok.
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 documentations were identified.
Event or Problem Description
Procedure performed: ap resection event description: used laparoscopically around the mesorectum on an ap resection.Small vessels as major vessels transected using a stapler small vessels in mesorectum being divided and not sealing at all.No alarm to alert and hence bleeding ensued.The device key had been discarded, so wont be returned for analysis.No clinical impact to patient.(b)(6) 2025 additional information received from territory manager via email.Just in case you hadn't noticed, but the first three questions were answered in the original report.Ap resection.But unaware how the case proceeded or whatever else they used as i wasn't present.And so, the last question, i can't answer and i'm unsure whether the surgeon would have noticed the activation tone or not.(b)(6) 2025 additional information received from territory manager via email in response to requested information "when the fuse button was pressed, did you notice the start tone or an ¿activating¿ message on the generator, or did the generator continue to show ¿ready¿ without any apparent activity? response: there was an activation tone but no alarm intervention: unsure about what else was used.Patient status: ok.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the device data key was missing.Testing was performed on the returned unit.However, without the data key, the complainant¿s experience could not be replicated or confirmed.Applied medical has reviewed the details surrounding the event and related products and is unable to determine the cause of the reported event or confirm that a product malfunction has occurred.Applied medical has performed a historical trend analysis and review of production records and no relevant documents were identified.
Event or Problem Description
Procedure performed: ap resection.Event description: used laparoscopically around the mesorectum on an ap resection.Small vessels as major vessels transected using a stapler small vessels in mesorectum being divided and not sealing at all.No alarm to alert and hence bleeding ensued.The device key had been discarded, so wont be returned for analysis.No clinical impact to patient.17.11.2025 additional information received from phil needes (territory manager) via email.Just in case you hadn't noticed, but the first three questions were answered in the original report.Ap resection.But unaware how the case proceeded or whatever else they used as i wasn't present.And so, the last question, i can't answer and i'm unsure whether the surgeon would have noticed the activation tone or not.18.11.2025 additional information received from phil needes (territory manager) via email in response to requested information "when the fuse button was pressed, did you notice the start tone or an ¿activating¿ message on the generator, or did the generator continue to show ¿ready¿ without any apparent activity? response: there was an activation tone but no alarm.Intervention: unsure about what else was used.Patient status: ok.

• Brand Name: VOYANT® 5MM 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: 23610480
• Report Number: 2027111-2025-00874
• Device Sequence Number: 9203880
• Product Code: GEI
• UDI-Device Identifier: 00607915138424
• UDI-Public: (01)00607915138424
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K201212
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/29/2026

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: EB210
• Device Catalogue Number: 101476439
• Device Lot Number: 1547301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2025
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 11/20/2025
• Supplement Report FDA Received Date: 03/18/2026; 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/31/2025
• 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
• Patient Sex: Unknown