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

Model Number	EB212
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2025
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 sent upon competition of investigation.
Event or Problem Description
Procedure performed: sentinel node biopsy and laparoscopic hysterectomy.Event description: laparoscopic sentinel node biopsy prior to hysterectomy.After 68 activations, while sealing the uterine artery, the jaws of the voyant became adhered to the vessel and could not be removed.Using monopolar and endoclips to stabilise the vessel, the jaws were peeled off the tissue.Surgeon then requested [competitor device] to complete the surgery.There was no clinical impact to the patient as a result of the event.Additional information was received from, amnz senior territory manager via email on 26-aug-2025: "further information pertaining to the device involved in this cer: lot#: 1549569.Serial #: (b)(6)" additional information was received from, amnz senior territory manager via email on 04-sep-2025: "no, when the jaws became adhered to the tissue, they could not remove the device.They then used endoclips to stabilize the vessel and monopolar to peel off the voyant jaws." patient status: stable.Intervention: using monopolar and endoclips to stabilise the vessel, the jaws were peeled off the tissue.Surgeon then requested [competitor device] to complete the surgery.
Event or Problem Description
Procedure performed: sentinel node biopsy and laparoscopic hysterectomy.Event description: laparoscopic sentinel node biopsy prior to hysterectomy.After 68 activations, while sealing the uterine artery, the jaws of the voyant became adhered to the vessel and could not be removed.Using monopolar and endoclips to stabilise the vessel, the jaws were peeled off the tissue.Surgeon then requested [competitor device] to complete the surgery.There was no clinical impact to the patient as a result of the event.Additional information was received from, amnz senior territory manager via email on 26-aug-2025: "further information pertaining to the device involved in this cer: lot#: 1549569.Serial#: (b)(6).Additional information was received from, amnz senior territory manager via email on 04-sep-2025: "no, when the jaws became adhered to the tissue, they could not remove the device.They then used endoclips to stabilize the vessel and monopolar to peel off the voyant jaws." patient status: stable.Intervention: using monopolar and endoclips to stabilise the vessel, the jaws were peeled off the tissue.Surgeon then requested [competitor device] to complete the surgery.
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-conformance's 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 trends were identified.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.Section d10 was corrected.
Event or Problem Description
Procedure performed: sentinel node biopsy and laparoscopic hysterectomy.Event description: laparoscopic sentinel node biopsy prior to hysterectomy.After 68 activations, while sealing the uterine artery, the jaws of the voyant became adhered to the vessel and could not be removed.Using monopolar and endoclips to stabilise the vessel, the jaws were peeled off the tissue.Surgeon then requested [competitor device] to complete the surgery.There was no clinical impact to the patient as a result of the event.Additional information was received from, amnz senior territory manager via email on 26-aug-2025: "further information pertaining to the device involved in this cer: lot#: 1549569 serial #: (b)(6).Additional information was received from, amnz senior territory manager via email on 04-sep-2025: "no, when the jaws became adhered to the tissue, they could not remove the device.They then used endoclips to stabilize the vessel and monopolar to peel off the voyant jaws." patient status: stable.Intervention: using monopolar and endoclips to stabilise the vessel, the jaws were peeled off the tissue.Surgeon then requested [competitor device] to complete the surgery.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Testing was performed on the event unit.However, the complainant¿s experience could not be replicated or confirmed as the event unit met current specifications and there were no visible non-conformances.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 occurred.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 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: 23096411
• Report Number: 2027111-2025-00767
• Device Sequence Number: 13091653
• Product Code: GEI
• UDI-Device Identifier: 00607915140793
• UDI-Public: (01)00607915140793
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/24/2026

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: EB212
• Device Catalogue Number: 101477723
• Device Lot Number: 1549569
• 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: 08/25/2025
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 09/19/2025
• Supplement Report FDA Received Date: 12/16/2025; 04/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/28/2025
• 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: ENDOCLIPS.; MONOPOLAR.; [COMPETITOR DEVICE].
• Patient Sex: Unknown