MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES EB216, VOYANT MARYLAND FUSION 44CM, 6/BX; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	EB216
Medical Device Problem Code	Self-Activation or Keying (1557)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Testing was performed on the returned unit, where it was observed that the device would unintentionally deliver rf energy, confirming the complainant¿s experience.Upon closer inspection, an internal fuse switch, was observed to be misaligned.Based on the condition of the returned unit and the description of the event, it is likely that the reported event was caused by the misaligned fuse switch.Based upon the initial description of the event, the event was not reportable as it is unlikely to cause or contribute to death or serious injury.However, based on the evaluation of the returned unit, applied medical determined that this event is reportable as unintended rf output could cause or contribute to death or serious injury.This report is a combined initial and follow-up report.
Event or Problem Description
Procedure performed: laparoscopic gastric sleeve.Event description: surgeon reports that fuse activation button would cause delayed and prolonged response during use.Energy delivery occurred a few seconds after pressing the fuse activation button in procedure.Upon releasing fuse activation button and removing device from tissue, energy was still being delivered to the device until an error code interrupted the seal cycle.A new device was opened to complete the case.No patient injury occurred.Product is available for return.Intervention: a new device was opened to complete the case.Patient status: no patient injury occurred.

• Brand Name: EB216, VOYANT MARYLAND FUSION 44CM, 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: aaron fulcher ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497135765
• MDR Report Key: 15530562
• Report Number: 2027111-2022-00755
• Device Sequence Number: 19459422
• Product Code: GEI
• UDI-Device Identifier: 00607915139360
• UDI-Public: (01)00607915139360(17)250213(30)01(10)1444896
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K200598
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/13/2025
• Device Model Number: EB216
• Device Catalogue Number: 101475464
• Device Lot Number: 1444896
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2022
• Initial Report FDA Received Date: 10/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/14/2022
• 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
• Patient Sex: Unknown