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	Energy Output Problem (1431)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2022
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: exploratory laparotomy- gynecology.Event description: the device was being used to seal and divide vessel and tissue in the abdominal cavity during the surgery after 3 hours and 15 minutes surgery the surgeon felt that the hemostasis of voyant wasn´t good enough.Intervention: the surgeon change voyant with [non-applied device] for sealing and dividing tissue and vessels.Patient status: after the surgery the patient went for observation at the icu.
Event or Problem Description
Procedure performed: exploratory laparotomy- gynecology.Event description: the device was being used to seal and divide vessel and tissue in the abdominal cavity during the surgery.After 3 hours and 15 minutes surgery the surgeon felt that the hemostasis of voyant wasn´t good enough.Additional information via email received by applied medical rep on 25oct22: the patient wasn't admitted to the icu as a result of this incident.The patient has been discharged from the icu.The generator made the end-tone signal.The surgeon did activate the blade after hearing the end tone.Not sure if there was bleeding since it was in a place with a lot of pressure from aorta.Additional information via email received by applied medical rep on 10jan23: the doctor is no longer employed at this hospital and it is therefore not possible for me to get additional information.Intervention: the surgeon change voyant with thunderbeat for sealing and dividing tissue and vessels patient status: after the surgery the patient went for observation at the icu - update 25oct22: the patient has been discharged from the icu.
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 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 or confirm that a product malfunction occurred.This event was initially reported based on the description of the event received at complaint intake.However, based on the evaluation of the returned unit and additional information of the event description received, applied medical determined that this event is not reportable as it is unlikely to cause or contribute to death or serious injury as the blood loss was able to be resolved with normal surgical procedural methods.Correction: h6 (health effect - impact code) is being corrected from ¿4608 ¿ intensive care¿ to ¿2199 - no health consequences or impact¿ as the complainant confirmed that the admission to the icu was not a result of the alleged device malfunction.

• 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: 15663883
• Report Number: 2027111-2022-00786
• Device Sequence Number: 12379655
• Product Code: GEI
• UDI-Device Identifier: 00607915139377
• UDI-Public: (01)00607915139377(17)250512(30)01(10)1452647
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• 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): 02/01/2023

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: 05/12/2025
• Device Model Number: EB217
• Device Catalogue Number: 101475458
• Device Lot Number: 1452647
• 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: 09/28/2022
• Supplement Date Received by Manufacturer: 09/28/2022
• Initial Report FDA Received Date: 10/24/2022
• Supplement Report FDA Received Date: 02/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/13/2022
• 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