MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES EB030, VOYANT FINE FUSION DEVICE, 6/BX; GEI

Model Number	EB030
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident device is anticipated to return.A follow-up report will be provided upon completion of investigation.
Event or Problem Description
Procedure performed: total thyroidectomy.Incident description: the intervention on the right lobe of the thyroid went well but once arrived on the dissection of the superior pole of the left lobe and after having activated the fusion then sectioned, there was a bleeding as if the fusion had not worked.The generator did not report any malfunction.The surgeon had to stop the bleeding (classic bi-polar) which was long and complicated.It would seem, according to the surgeon and his operative assistance, that a suspicious noise would have been heard just before this activation.An element of the device would have broken preventing the operation of the fusion but without it being reported by the generator the device has unfortunately not been preserved.A second eb030 was given to the surgeon to finish the intervention.There were no consequences for the patient other than blood loss and this generated a lot of stress for the surgeon and his entire team.Additional information received by phone from the sales rep on 5feb19: there was no tension applied to a vessel or bundle that was being sealed.When the surgeon started noticing the insufficient hemostasis, the device was being used for about 15 activations.Insufficient hemostasis was observed one time.There was no eschar buildup on the jaws when the insufficient hemostasis was observed.The jaws of the device were cleaned during the procedure, at least one time, with humid compress the surgeon did not notice any improvement with hemostasis if/when the jaws were cleaned.Insufficient hemostasis was observed in the middle of the jaws sealing site.The jaws were not surrounded by fluid when the device was activated and the insufficient hemostasis was observed.The patient did not exhibit any vascular pathology.The device was not activated on diseased or inflamed tissue.The patient was not given anticoagulation medicine.The amount of bleeding observed is unknown.Transfusion was not required intervention: a second eb030 was given to the surgeon to finish the intervention.Patient status: no patient injury or illness did occur associated with the complaint event.
Event or Problem Description
Procedure performed: total thyroidectomy.Incident description: the intervention on the right lobe of the thyroid went well but once arrived on the dissection of the superior pole of the left lobe and after having activated the fusion then sectioned, there was a bleeding as if the fusion had not worked.The generator did not report any malfunction.The surgeon had to stop the bleeding (classic bi-polar) which was long and complicated.It would seem, according to the surgeon and his operative assistance, that a suspicious noise would have been heard just before this activation.An element of the device would have broken preventing the operation of the fusion but without it being reported by the generator the device has unfortunately not been preserved.A second eb030 was given to the surgeon to finish the intervention.There were no consequences for the patient other than blood loss and this generated a lot of stress for the surgeon and his entire team.Additional information received by phone from the sales rep on 5feb19: there was no tension applied to a vessel or bundle that was being sealed.When the surgeon started noticing the insufficient hemostasis, the device was being used for about 15 activations.Insufficient hemostasis was observed one time.There was no eschar buildup on the jaws when the insufficient hemostasis was observed.The jaws of the device were cleaned during the procedure, at least one time, with humid compress the surgeon did not notice any improvement with hemostasis if/when the jaws were cleaned.Insufficient hemostasis was observed in the middle of the jaws sealing site.The jaws were not surrounded by fluid when the device was activated and the insufficient hemostasis was observed.The patient did not exhibit any vascular pathology.The device was not activated on diseased or inflamed tissue.The patient was not given anticoagulation medicine.The amount of bleeding observed is unknown.Transfusion was not required intervention: a second eb030 was given to the surgeon to finish the intervention.Patient status: no patient injury or illness did occur associated with the complaint event.
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.The event unit met current specifications and there were no visible non-conformances.Although the exact root cause of the reported event could not be determined, applied medical will continue to monitor its vigilance system for trends and take appropriate actions, as necessary, to ensure the performance and safety of its products.

• Brand Name: EB030, VOYANT FINE FUSION DEVICE, 6/BX
• Common Device Name: GEI
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 8340019
• Report Number: 2027111-2019-00347
• Device Sequence Number: 2284260
• Product Code: GEI
• UDI-Device Identifier: 00607915127428
• UDI-Public: (01)00607915127428(17)200215(30)01(10)1333208
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K153017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2019

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: 02/15/2020
• Device Model Number: EB030
• Device Catalogue Number: 101223301
• Device Lot Number: 1333208
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/21/2019
• Supplement Date Received by Manufacturer: 01/21/2019
• Initial Report FDA Received Date: 02/14/2019
• Supplement Report FDA Received Date: 04/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1