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

Model Number	EB030
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	Injury (2348)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.As the event unit was not returned, testing was unable to be performed and the complainant's experience could not be replicated or confirmed.Applied medical has reviewed the details surrounding the event and related products.At this time, applied medical is unable to determine the cause of the injury or confirm that a product malfunction occurred.Applied medical will monitor its vigilance systems for any developing trends.This document represents the initial and final report.
Event or Problem Description
Procedure performed: translation ame: hemorrhoidectomy.Translation ame: the surgery went well.After a while (exact time to be confirmed) there was hemorrhaging.Additional information received from the sales rep by phone on 15 mar 2018: there was no bleeding observed during the surgery.Sealing a vessel or tissue bundle did not directly lead to bleeding.Small arteries and hemorrhoid tissue bundle were being sealed.During the surgery there was no insufficient hemostasis observed.There was no tension applied to a vessel or bundle that was being sealed.The patient did not exhibit any vascular pathology.The device was activated on some inflamed tissues.The patient was not given anticoagulation medicine.The hospital confirmed that these incidents occurred with 3 patients between (b)(6) 2018.Patient 3 will be associated to (b)(4).Patient status: today the patient is fine.

• Brand Name: EB030, VOYANT FINE FUSION, 6/BX
• Common Device Name: GEI
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 7403888
• Report Number: 2027111-2018-00135
• Device Sequence Number: 785284
• Product Code: GEI
• UDI-Device Identifier: 00607915127428
• UDI-Public: (01)00607915127428(17)180503(30)01(10)1309582
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Report Date (Section B): 04/06/2018

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: 05/03/2018
• Device Model Number: EB030
• Device Catalogue Number: 101223301
• Device Lot Number: 1309582
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2018
• Initial Report FDA Received Date: 04/06/2018
• Patient Sequence Number: 1