MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES EB240, VOYANT OPEN FUSION, 6 B/X; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	EB240
Medical Device Problem Codes	Failure to Deliver Energy (1211); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit has been returned to applied medical for evaluation.A follow-up report will be submitted upon completion of investigation.
Event or Problem Description
Procedure performed: open cholectomy event description: two related complaints occurred in the same procedure.Complaint 1 of 2: # (b)(4) complaint 2 of 2: # (b)(4).The rep was not present in the case.The staff relayed to the rep that the fuse button was not working and the device was not sealing.No energy was being delivered and the case was extremely bloody.This issue was observed at the beginning of the case, approximately 2-5 activations into the case.After this eb240 issue occurred, a second eb240 was opened but the same issue with the fuse button not working occurred again.The case was completed with [competitor device].The type of tissue being grasped during the event is unknown, but it is possible that it was mesentary tissue.They did hear the activation tone and end tone.It is unknown if thermal effects were visible at the site.It is unknown if the blade was deployed during the event.The product is available for return.Type of intervention: opened [competitor device] patient status: fine.
Event or Problem Description
Procedure performed: open cholectomy.Event description: two related complaints occurred in the same procedure.Complaint 1 of 2: #(b)(4).Complaint 2 of 2: #(b)(4).The rep was not present in the case.The staff relayed to the rep that the fuse button was not working and the device was not sealing.No energy was being delivered and the case was extremely bloody.This issue was observed at the beginning of the case, approximately 2-5 activations into the case.After this eb240 issue occurred, a second eb240 was opened but the same issue with the fuse button not working occurred again.The case was completed with [competitor device].The type of tissue being grasped during the event is unknown, but it is possible that it was mesentary tissue.They did hear the activation tone and end tone.It is unknown if thermal effects were visible at the site.It is unknown if the blade was deployed during the event.The product is available for return.Type of intervention: opened [competitor device].Patient status: fine.
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 could not be replicated as there were no non-conformances found with the electrical components of the device.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.Applied medical has performed a historical trend analysis and review of production records and no trends were identified.This event was initially reported based on the description of the event.However, based on the evaluation of the returned unit, applied medical determined that this event is not reportable as it is unlikely to cause or contribute to death or serious injury.

• Brand Name: EB240, VOYANT OPEN FUSION, 6 B/X
• 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: 19293540
• Report Number: 2027111-2024-00637
• Device Sequence Number: 8693734
• Product Code: GEI
• UDI-Device Identifier: 00607915138455
• UDI-Public: (01)00607915138455(17)260216(30)01(10)1513193
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K201212
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2024

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: 02/16/2026
• Device Model Number: EB240
• Device Catalogue Number: 101474615
• Device Lot Number: 1513193
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2024
• 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: 04/17/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/10/2024
• Supplement Report FDA Received Date: 10/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/29/2023
• 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: LIGASURE
• Patient Sex: Unknown