MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES EB210, VOYANT 5MM FUSION 37CM, 6/BX; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	EB210
Medical Device Problem Codes	Energy Output Problem (1431); Self-Activation or Keying (1557)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit is anticipated to return to applied medical for evaluation.A follow-up report will be provided upon completion of investigation.
Event or Problem Description
Procedure performed: [gastric sleeve].Event description: hospital: [hospital name].[name] at [hospital name] was performing a gastric sleeve procedure where he was using eb210 batch# 1493746 expiration date 2026-06-19.Voyant generator ea020 s/n (b)(6).According to the doctor, he started pressing the fuse activation button to cauterize some vessels but after a couple of activactions it was sending the tone but it wasn´t cauterizing at all and no error was showing in the generator screen, as it appeared as the cycle was completed.He activated for another cycle and the cauterization was not performed again, so the surgeon opted to ask for another device.They offered him an eb215 maryland fusion device and he didn´t experienced any issues at all.The patient health was not compromised in any moment during the procedure.Here is to mention that the device was brand new, as per what they said to us.We were not present at the moment the procedure took place, so we talked with the staff of the integrated service who offers the devices to the hospital (control scientific) so they could share with us their testimonies.The device used will be handled to us in the main white box which was opened for the procedure.The failure took place on thursday (b)(6).Type of intervention: the case was completed with eb215.Patient status: [the patient health was not compromised in any moment during the procedure].
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.As the event unit was not returned, applied medical is unable to determine if the event unit exhibited any non-conformances that could have contributed to the reported event.In the absence of the event unit, it is difficult to determine if the reported event was caused by a manufacturing non-conformance or circumstantial factors at the time of use.Applied medical has reviewed the details surrounding the event and is unable to determine the exact root cause of the event.Applied medical has performed a historical trend analysis and review of production records and no relevant documentations were identified.This event was initially reported based on the description of the event.However, based on further examination of the event description, applied medical determined that this event is not reportable as it is unlikely to cause or contribute to death or serious injury in the state of health.
Event or Problem Description
Procedure performed: [gastric sleeve].Event description: hospital: [hospital name].[name] at [hospital name] was performing a gastric sleeve procedure where he was using eb210 batch# 1493746 expiration date 2026-06-19.Voyant generator ea020 s/n (b)(6).According to the doctor, he started pressing the fuse activation button to cauterize some vessels but after a couple of activactions it was sending the tone but it wasn´t cauterizing at all and no error was showing in the generator screen, as it appeared as the cycle was completed.He activated for another cycle and the cauterization was not performed again, so the surgeon opted to ask for another device.They offered him an eb215 maryland fusion device and he didn´t experienced any issues at all.The patient health was not compromised in any moment during the procedure.Here is to mention that the device was brand new, as per what they said to us.We were not present at the moment the procedure took place, so we talked with the staff of the integrated service who offers the devices to the hospital (control scientific) so they could share with us their testimonies.The device used will be handled to us in the main white box which was opened for the procedure.The failure took place on thursday june the 27th.Type of intervention: the case was completed with eb215.Patient status: [the patient health was not compromised in any moment during the procedure].

• Brand Name: EB210, VOYANT 5MM FUSION 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: 19808777
• Report Number: 2027111-2024-00749
• Device Sequence Number: 12626021
• Product Code: GEI
• UDI-Device Identifier: 00607915138424
• UDI-Public: (01)00607915138424(17)260619(30)01(10)1493746
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2024

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: 06/19/2026
• Device Model Number: EB210
• Device Catalogue Number: 101475457
• Device Lot Number: 1493746
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/23/2024
• Supplement Report FDA Received Date: 10/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/20/2023
• 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