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

Model Number	EB230
Medical Device Problem Code	Excessive Heating (4030)
Health Effect - Clinical Code	Burn(s) (1757)
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: ni.Event description: "she used eb230 last week for breast op case.Our distributor gave eb230 to her for sampling and she used.And today i and our distributor's representative went to see her and she said that the jaw has a problem.The problem is the heat problem.The heat get out from jaw site and reach out to proximal from the jaw tip.So organs or vessels' burned residues remain dirtily.And she said that she used [competitor device] and there are some margins in their jaw.So the heat never reach out to that point." product is not available for return.This is 'sample' case.Additional information was received via email on 12aug2024: "there was unintended tissue burns or unintended damage.The unintended rf energy output from the device occur.The surgeon did not use multiple seals on the same tissue." type of intervention: the case was completed with the new device.Patient status: unintended tissue burns or unintended damage.
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.
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation, and the lot number was not provided.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 documentation was identified.
Event or Problem Description
Procedure performed: ni event description: "she used eb230 last week for breast op case.Our distributor gave eb230 to her for sampling and she used.And today i and our distributor's representative went to see her and she said that the jaw hava a problem.The problem is the heat problem.The heat get out from jaw site and reach out to proximal from the jaw tip.So organs or vessels' burned residues remain dirtily.And she said that she used [competitor device] and there are some margins in their jaw.So the heat never reach out to that point." *product is not available for return.*this is 'sample' case.**additional information was recieved via email on 12aug2024: "there was unintended tissue burns or unintended damage.The unintended rf energy output from the device occur.The surgeon did not use multiple seals on the same tissue." type of intervention: the case was completed with the new device.Patient status: unintended tissue burns or unintended damage.

• Brand Name: VOYANT® FINE 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: farah azmi ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497138710
• MDR Report Key: 20052036
• Report Number: 2027111-2024-00794
• Device Sequence Number: 7934148
• Product Code: GEI
• UDI-Device Identifier: 00607915138240
• UDI-Public: (01)00607915138240
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K202818
• 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): 11/11/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: EB230
• Device Catalogue Number: 101475993
• 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: 08/12/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/23/2024
• Supplement Report FDA Received Date: 11/11/2024
• 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: GENERATOR
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown