MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES EB217, VOYANT MARYLAND FUSION 23CM, 6/BX; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	EB217
Medical Device Problem Code	Failure to Deliver Energy (1211)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event device is anticipated to be returned to applied medical for evaluation.A follow-up report will be provided upon completion of investigation.
Event or Problem Description
Procedure performed: pancreaticoduodenectomy.Event description: sealing and cutting action was being performed when the event occurred.The device does not work when activating the sealing switch, sealing does not occur.Additional information received from applied medical representative via email 3nov2022: the ready message was displayed on the screen when the device was connected.They did not receive any alarms.The activation tone or end tone was heard when the fuse activation button was pressed.Thermal effects were not visible at the seal site.Peritoneum section was being grasped when the even happened.The device had been used for 20-25 activations before the experience was observed.Intervention: replacing the device with a new one.Patient status: favorable.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Testing was performed on the event unit.However, the complainant¿s experience of low energy output could not be replicated or confirmed, as the event unit functioned as intended.The event unit met current specifications and there were no visible non-conformances.Applied medical has reviewed the details surrounding the event and related products and is unable to determine the cause of the reported event based on the evaluation of the returned unit or confirm that a product malfunction occurred.
Event or Problem Description
Procedure performed: pancreaticoduodenectomy.Event description: sealing and cutting action was being performed when the event occurred.The device does not work when activating the sealing switch, sealing does not occur.Additional information received from applied medical representative via email 3nov22: the ready message was displayed on the screen when the device was connected.They did not receive any alarms.The activation tone or end tone was heard when the fuse activation button was pressed.Thermal effects were not visible at the seal site.Peritoneum section was being grasped when the even happened.The device had been used for 20-25 activations before the experience was observed.Intervention: replacing the device with a new one.Patient status: favorable.

• Brand Name: EB217, VOYANT MARYLAND FUSION 23CM, 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: 15794428
• Report Number: 2027111-2022-00818
• Device Sequence Number: 3038681
• Product Code: GEI
• UDI-Device Identifier: 00607915139377
• UDI-Public: (01)00607915139377(17)250519(30)01(10)1453205
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K200598
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2023

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: 05/19/2025
• Device Model Number: EB217
• Device Catalogue Number: 101475458
• Device Lot Number: 1453205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2022
• Supplement Date Received by Manufacturer: 11/03/2022
• Initial Report FDA Received Date: 11/14/2022
• Supplement Report FDA Received Date: 02/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/20/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GENERATOR.
• Patient Sex: Unknown