MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES EB230, VOYANT FINE FUSION, 6/BX; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	EB230
Medical Device Problem Code	Excessive Heating (4030)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	12/29/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Procedure performed: thyroidectomy.Event description: [name of hospital]."thin burns on the patient's neck after surgery.When eb230 is activated, heat is generated on the back of the round plate of jaws.High fever is felt when touched by hand." product is available for return.Two units will be returned.Two of eb230 were used on the event date - one was used in the morning and the other one was used in the afternoon, but it is uncertain which unit is the event device.The device with a device log showing the activations were done in the morning (korea time) would be the event unit.Intervention: ni.Patient status: the patient got a burn on his neck.
Additional Manufacturer Narrative
The event unit is anticipated to return to applied medical for evaluation.A follow-up report will be submitted upon completion of investigation.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation, along with photos of the event.Visual inspection confirmed the complainant¿s experience of unintended thermal damage.Based on the evaluation of the event unit and the description of the event, it is likely that the reported event was caused by using the device to manipulate tissue before allowing the jaws to cool.The instructions for use (ifu) states to ¿keep the jaws of the device away from adjacent tissue as the jaws may remain hot enough to cause burns¿.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: thyroidectomy.Event description: (b)(6)] "thin burns on the patient's neck after surgery.When eb230 is activated, heat is generated on the back of the round plate of jaws.High fever is felt when touched by hand." product is available for return.Two units will be returned.Two of eb230 were used on the event date - one was used in the morning and the other one was used in the afternoon, but it is uncertain which unit is the event device.The device with a device log showing the activations were done in the morning (korea time) would be the event unit.Additional information received on 19apr24: "i¿ve spoken with the territory manager.According to him, the burn on the patient¿s neck was not that serious and the heat from the device caused blister on the patient¿s neck.They just applied a wound dressing and the patient was discharged from hospital.It didn¿t leave a scar." intervention: they just applied a wound dressing and the patient was discharged from hospital.It didn¿t leave a scar.Patient status: the patient got a burn on his neck.

• Brand Name: EB230, VOYANT FINE FUSION, 6/BX
• 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: 18499206
• Report Number: 2027111-2024-00318
• Device Sequence Number: 18095658
• Product Code: GEI
• UDI-Device Identifier: 00607915138240
• UDI-Public: (01)00607915138240(17)260502(30)01(10)1490572
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/02/2026
• Device Model Number: EB230
• Device Catalogue Number: 101475993
• Device Lot Number: 1490572
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/02/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/11/2024
• Supplement Report FDA Received Date: 08/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/03/2023
• 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