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 Code	Excessive Heating (4030)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	01/29/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The event unit is not returning to applied medical for evaluation.A follow-up report will be submitted upon completion of investigation.
Event or Problem Description
Procedure performed: hysterectomy.Event description: hospital: [hospital name] notes on feedback 7428: surgeon stated outside of jaw was quite hot - accidentally nicked the bladder and surgeon reported left slight singe.No adverse outcome for patient.Device also stuck around ip - stickiness was on the jaw edge.Surgeon noted that when sealing and transecting, cut length wasn't consistent - sometimes shorter.Description of event: sealing and dividing tissue as part of hysterectomy procedure.Surgeon stated outside of jaw was quite hot - accidentally nicked the bladder and surgeon reported left slight singe.No adverse outcome for patient.Device also stuck around ip - stickiness was on the jaw edge.Surgeon noted that when sealing and transecting, cut length wasn't consistent - sometimes shorter.There was no clinical impact to the patient as a result of the event.The user resolved the situation with no change to procedure, continued with device throughout whole procedure and completed the procedure successfully.Type of intervention: no change to procedure, continued with device throughout whole procedure and completed procedure successfully.Patient status: recovered well.
Event or Problem Description
Procedure performed: hysterectomy.Description of event: surgeon stated outside of jaw was quite hot - accidentally nicked the bladder and surgeon reported left slight singe.No adverse outcome for patient.Device also stuck around ip - stickiness was on the jaw edge.Surgeon noted that when sealing and transecting, cut length wasn't consistent - sometimes shorter.Sealing and dividing tissue as part of hysterectomy procedure.Surgeon stated outside of jaw was quite hot - accidentally nicked the bladder and surgeon reported left slight singe.No adverse outcome for patient.Device also stuck around ip - stickiness was on the jaw edge.Surgeon noted that when sealing and transecting, cut length wasn't consistent - sometimes shorter.There was no clinical impact to the patient as a result of the event.The user resolved the situation with no change to procedure, continued with device throughout whole procedure and completed the procedure successfully.Additional information was received from an ama surgical specialist: "sticking did not lead to bleeding.It was the last seal of the procedure and it was the specimen side of the seal that stuck to the jaws.As the device was pulled toward the surgeon the specimen came with it.The surgeon tried applying energy with the jaws open such that the specimen would come off but couldn't reach the activation button (single step) and eventually the specimen just fell off the jaws on its own / became unstuck." type of intervention: no change to procedure, continued with device throughout whole procedure and completed procedure successfully.Patient status: recovered well.
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 trends were identified.

• 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: 21344952
• Report Number: 2027111-2025-00353
• Device Sequence Number: 21072704
• Product Code: GEI
• UDI-Device Identifier: 00607915140793
• UDI-Public: (01)00607915140793
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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
• Report Date (Section B): 05/22/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: EB212
• Was Device Available for Evaluation?: No
• 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: 01/29/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/10/2025
• Supplement Report FDA Received Date: 05/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: GELPOINT VPATH.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown