MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES VOYANT® 5MM FUSION DEVICE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	EB210
Medical Device Problem Codes	Self-Activation or Keying (1557); Failure to Seal (4070)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2024
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] [according to the doctor, he started pressing the fuse activation button to cauterize some vessels but after two or three 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 name] so they could share with us their testimonies.The device used was handled to us in the main white box which was opened for the procedure.The failure took place on saturday june the 22th but they informed to us on tuesday june the 25th.Type of intervention: [eb210 was replaced with eb215] patient status: [unk].
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 or confirmed as the unit met specifications and there were no visible nonconformances.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.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 further examination of the event description, applied medical determined that this event is not reportable as it is unlikely to lead to death or serious deterioration in the state of health.Corrections were performed for section d1to update the brand name.
Event or Problem Description
Procedure performed: [gastric sleeve].Event description: hospital: [hospital name] according to the doctor, he started pressing the fuse activation button to cauterize some vessels but after two or three activations 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 was handled to us in the main white box which was opened for the procedure.The failure took place on saturday (b)(6) but they informed to us on tuesday (b)(6).Type of intervention: [eb210 was replaced with eb215].Patient status: [no patient injury indicated].

• Brand Name: VOYANT® 5MM FUSION DEVICE
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: ashleigh mendez ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497135359
• MDR Report Key: 19812899
• Report Number: 2027111-2024-00750
• Device Sequence Number: 8891569
• Product Code: GEI
• UDI-Device Identifier: 00607915138424
• UDI-Public: (01)00607915138424(17)260509(30)01(10)1486760
• Combination Product (Y/N): N
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2025

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: 05/09/2026
• Device Model Number: EB210
• Device Catalogue Number: 101475457
• Device Lot Number: 1486760
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/23/2024
• Supplement Report FDA Received Date: 01/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/10/2023
• 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