MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES EB212, VOYANT MARYLAND SINGLE 37CM, 6/BX; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	EB212
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	03/29/2023
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
Procedure performed: laparoscopic hand-assisted donor nephrectomy event description: eb212 jaws got hot and burned the back of kidney.Handle was reported to not feel correct, and felt locked out.Product is available for return.Additional information received on 29mar2023 via email from account manager: the burn occurred immediately after firing on adjacent tissue.The device had been used for approximately 10 activations before the experience was observed.No generator alarms occurred.The jaws of the device were cleaned every 10-15 activations.No audible noise or visual damage was observed to the device prior to the handle feeling locked out.Physician reports throughout the case the device felt different, harder to close jaws and activate.Additional information received on (b)(6) 2023 via email from account manager: no intervention needed for the burn.Type of intervention: opened new eb212, completed successfully.No intervention needed for the burn.Patient status: case completed.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Testing was performed on the returned unit, where the device passed all relevant testing and functioned as intended.Based on the evaluation of the returned unit and the description of the event provided by the user, it is likely that the event was caused due to circumstantial factors at the time of use.Applied medical instructions for use (ifu) warns that, ¿after device activation, keep the jaws of the device away from adjacent tissue as the jaws may remain hot enough to cause burns.¿.
Event or Problem Description
Procedure performed: laparoscopic hand-assisted donor nephrectomy event description: eb212 jaws got hot and burned the back of kidney.Handle was reported to not feel correct, and felt locked out product is available for return.Additional information received on 29mar2023 via email from account manager: the burn occurred immediately after firing on adjacent tissue.The device had been used for approximately 10 activations before the experience was observed.No generator alarms occurred.The jaws of the device were cleaned every 10-15 activations.No audible noise or visual damage was observed to the device prior to the handle feeling locked out.Physician reports throughout the case the device felt different, harder to close jaws and activate.Additional information received on 31mar2023 via email from account manager: no intervention needed for the burn.Type of intervention: opened new eb212, completed successfully.No intervention needed for the burn.Patient status: case completed.

• Brand Name: EB212, VOYANT MARYLAND SINGLE 37CM, 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: 16683305
• Report Number: 2027111-2023-00408
• Device Sequence Number: 7293157
• Product Code: GEI
• UDI-Device Identifier: 00607915140793
• UDI-Public: (01)00607915140793(17)250915(30)01(10)1462872
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2023

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: 09/15/2025
• Device Model Number: EB212
• Device Catalogue Number: 101474715
• Device Lot Number: 1462872
• 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: 03/29/2023
• Supplement Date Received by Manufacturer: 03/29/2023
• Initial Report FDA Received Date: 04/05/2023
• Supplement Report FDA Received Date: 08/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/16/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown