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

Model Number	EB210
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: tlh.Event description: [name redacted] did a tlh with the eb210.The jaw would not open upon unlatching the handle during the procedure.Visual inspection shows the device key cut and discards and unlatched handle with the jaw of the device closed.Some eschar build up seen at the outside of the jaw.Additional information received from an applied medical representative via email on 01sep2025: the instrument¿s jaw did not open anymore midway of the procedure.The instrument was cleaned multiple time before it occurred.[name] had no warning signs, noise or alike preceding the event.All worked fine until the jaw blocked.The instrument¿s jaw was not stuck on tissue.[name] has tried to open by forcing closing and unlatching the handgrip multiple times without effect.He completed the procedure with another eb210 and without issues.No particular additional circumstances.Patient status: ok.Intervention: completed the procedure with another eb210.
Additional Manufacturer Narrative
The event unit is anticipated to return to applied medical for evaluation.A follow-up report will be sent upon completion of investigation.
Event or Problem Description
Procedure performed: tlh.Event description: [name redacted] did a tlh with the eb210.The jaw would not open upon unlatching the handle during the procedure.Visual inspection shows the device key cut and discards and unlatched handle with the jaw of the device closed.Some eschar build up seen at the outside of the jaw.Additional information received from an applied medical representative via email on 01sep25: the instrument¿s jaw did not open anymore midway of the procedure.The instrument was cleaned multiple time before it occurred.[name] had no warning signs, noise or alike preceding the event.All worked fine until the jaw blocked.The instrument¿s jaw was not stuck on tissue.[name] has tried to open by forcing closing and unlatching the handgrip multiple times without effect.He completed the procedure with another eb210 and without issues.No particular additional circumstances.Additional information received from an applied medical representative via email on 05sep25: unknown whether blade lever not returning to forward position when released.It was stuck all of a sudden according to [name redacted].Midway through a tlh when the incident was observed.Device key was cut and discarded so engineering can't' check.Patient status: ok.Intervention: completed the procedure with another eb210.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation without the device key.Functional testing was performed on the event unit, where the complainant¿s experience of jaws staying closed was confirmed.Visual inspection was performed and the blade was observed to be stuck within the blade channel.Based on the evaluation of the event unit and the description of the event, it is likely that the reported event was caused by the eschar build up within the blade channel, which prevented the blade from fully returning.Applied medical has performed a historical trend analysis and review of production records and no relevant documentation was identified.This event was initially reported based on the description of the event.However, based on further examination of the event description and the evaluation of the returned unit, applied medical determined that this event is not reportable as it is unlikely to lead to death or serious deterioration in the state of health.

• 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: 22955942
• Report Number: 2027111-2025-00736
• Device Sequence Number: 15518844
• Product Code: GEI
• UDI-Device Identifier: 00607915138424
• UDI-Public: (01)00607915138424
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2025

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: EB210
• Device Catalogue Number: 101476432
• Device Lot Number: 1536857
• 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: 08/28/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/03/2025
• Supplement Report FDA Received Date: 12/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/03/2024
• 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: STANDARD LAP INSTRUMENTS.
• Patient Sex: Unknown