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	09/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: hemicolectomy.Event description: the device malfunctioned towards the end of the operation.It worked well for the first few hours of the operation.The surgeon simply closed the handle and was unable to reopen it.I tested the device myself today and i could not open the handle either.It is completly stuck.The other devices of the same lot are working properly.Additional information received by applied medical rep via email on 22sep25: it is unknown what caused the jaws to be locked closed.The surgeon just used the device plastic to plastic and was unable to open it again.No audible or visual damage to the device prior to the incident.The handle lever itself was completely stuck.Not just the jaws.They cut the tissue and were able to remove the device with locked jaws/handle.There was some minor tissue damage.It was observed once because they were unable to open the jaws/handle.They had to use another dive afterwards.It had been used for several hours already.I would guess a few hundreds.It didn´t unlatch.They couldn´t open the jaws.Investigation: device replacement.Patient status: no clinical impact to the patient.
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.
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 the jaws not opening.The internal trigger component was observed to be bent.Based on the condition of the returned unit, it is likely that the reported event was caused by the bent trigger component, which prevented the jaws from opening.Applied medical has performed a historical trend analysis and review of production records and no relevant documentations were identified.Corrections performed to sections b5, e1 and e2.Corrections performed to update "investigation" to " intervention", "denmark" to "germany" and "no" to "yes".
Event or Problem Description
Procedure performed: hemicolectomy.Event description: the device malfunctioned towards the end of the operation.It worked well for the first few hours of the operation.The surgeon simply closed the handle and was unable to reopen it.I tested the device myself today and i could not open the handle either.It is completly stuck.The other devices of the same lot are working properly.Additional information received by applied medical rep via email on 22sep25: it is unknown what caused the jaws to be locked closed.The surgeon just used the device plastic to plastic and was unable to open it again.No audible or visual damage to the device prior to the incident.The handle lever itself was completely stuck.Not just the jaws.They cut the tissue and were able to remove the device with locked jaws/handle.There was some minor tissue damage.It was observed once because they were unable to open the jaws/handle.They had to use another dive afterwards.It had been used for several hours already.I would guess a few hundreds.It didn´t unlatch.They couldn´t open the jaws.Intervention: device replacement.Patient status: no clinical impact to the patient.

• 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: 23296576
• Report Number: 2027111-2025-00807
• Device Sequence Number: 4889645
• Product Code: GEI
• UDI-Device Identifier: 00607915139353
• UDI-Public: (01)00607915139353
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 01/14/2026

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: EB215
• Device Catalogue Number: 101477727
• Device Lot Number: 1545380
• 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: 09/12/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 01/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/13/2025
• 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: GENERATOR.; TROCARS.
• Patient Sex: Unknown