MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES EB213, VOYANT MARYLAND SINGLE 44CM, 6/BX; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	EB213
Medical Device Problem Code	Failure to Deliver Energy (1211)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.A follow-up report will be submitted upon completion of investigation.
Event or Problem Description
Procedure performed: laparoscopic gastric sleeve.Event description: rep was present for the case.The device did not produce energy on the first activation.The generator made normal activation and end tones.The surgeon tried again and the same thing occurred, no energy was delivered.The rep unplugged the handpiece from the generator and plugged it back in.The surgeon tried activating three more times and still no energy was delivered, the generator made the usual activation and end tones for each activation.The surgeon was sealing on the greater curvature of the stomach at the time of the event.There were no visible thermal effects and the generator functioned normally.The surgeon switched to a [competitor device] to complete the procedure and there was no patient injury.Product is available for return.Additional information received on (b)(6) 2023 via email from project manager: he did not transect after attempting to seal so no bleeding occurred.Thankfully the surgeon recognized there was no energy output right away despite the generator seal cycle and end tones.Type of intervention: the case was completed with a [competitor device].Patient status: no patient injury.
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 passed all relevant testing and met current specification.There were no visible nonconformances observed.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: laparoscopic gastric sleeve.Event description: rep was present for the case.The device did not produce energy on the first activation.The generator made normal activation and end tones.The surgeon tried again and the same thing occurred, no energy was delivered.The rep unplugged the handpiece from the generator and plugged it back in.The surgeon tried activating three more times and still no energy was delivered, the generator made the usual activation and end tones for each activation.The surgeon was sealing on the greater curvature of the stomach at the time of the event.There were no visible thermal effects and the generator functioned normally.The surgeon switched to a [competitor device] to complete the procedure and there was no patient injury.Product is available for return.Additional information received on 19sep2023 via email from project manager: he did not transect after attempting to seal so no bleeding occurred.Thankfully the surgeon recognized there was no energy output right away despite the generator seal cycle and end tones.Type of intervention: the case was completed with a [competitor device].Patient status: no patient injury.

• Brand Name: EB213, VOYANT MARYLAND SINGLE 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: farah azmi ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497138710
• MDR Report Key: 17901956
• Report Number: 2027111-2023-00625
• Device Sequence Number: 7468199
• Product Code: GEI
• UDI-Device Identifier: 00607915140809
• UDI-Public: (01)00607915140809(17)260322(30)01(10)1486326
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 02/16/2024

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: 03/22/2026
• Device Model Number: EB213
• Device Catalogue Number: 101474691
• Device Lot Number: 1486326
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2023
• Supplement Date Received by Manufacturer: 09/12/2023
• Initial Report FDA Received Date: 10/09/2023
• Supplement Report FDA Received Date: 02/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/23/2023
• 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
• Patient Sex: Unknown