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

Model Number	EB230
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Nerve Damage (1979)
Date of Event	02/23/2021
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: cervical lymph node dissection ( left and right ).Event description: dr [name] reported to me on (b)(6) 2021 that his patient, who had been operated on for cervical lymph node dissection, had postoperative complications resulting from nerves that were no longer functional leading to severe disorders that persisted until this day.The concomitance of these events with an undesirable complication of the patient postoperatively and of the trial with our voyant / ref eb230 device led dr.[name] to ask us about the thermal spread diffusion of our device.Furthermore, i would like to point out that nothing to report has been observed during the per-operation.Patient status: nerve damage.
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.As the event unit was not returned, testing was unable to be performed and applied medical was unable 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 root cause of the event.The probability and criticality of the harm resulting from this failure have been evaluated and were found to be at an acceptable level.
Event or Problem Description
Procedure performed: cervical lymph node dissection (left and right) event description: dr [name] reported to me on (b)(6) 2021 that his patient, who had been operated on for cervical lymph node dissection, had postoperative complications resulting from nerves that were no longer functional leading to severe disorders that persisted until this day.The concomitance of these events with an undesirable complication of the patient postoperatively and of the trial with our voyant/ref (b)(4) device led dr.[name] to ask us about the thermal spread diffusion of our device.Furthermore, i would like to point out that nothing to report has been observed during the per-operation.Patient status: nerve damage.

• 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
• MDR Report Key: 11599385
• Report Number: 2027111-2021-00409
• Device Sequence Number: 3415173
• Product Code: GEI
• UDI-Device Identifier: 00607915138240
• UDI-Public: (01)00607915138240(17)231013(30)01(10)1397540
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K153017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2021

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: 10/13/2023
• Device Model Number: EB230
• Device Catalogue Number: 101474248
• Device Lot Number: 1397540
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/11/2021
• Supplement Date Received by Manufacturer: 03/11/2021
• Initial Report FDA Received Date: 03/31/2021
• Supplement Report FDA Received Date: 04/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GENERATOR
• Outcome Attributed to Adverse Event: Other