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

Model Number	EB030
Medical Device Problem Code	Sticking (1597)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/27/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: 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.Although the root cause of the reported event could not be confirmed, 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.This report is being filed as a result of a retrospective review of applied medical's customer feedback data received between october 02, 2014 - june 01, 2016.The reviews ensured that past reportable events were appropriately identified and reported to the designated regulatory authority(ies).This report, which represents the initial and final reports combined, is being submitted based on the findings of that retrospective review.
Event or Problem Description
Procedure performed: thyroidectomy.Translation: second test highlights the tendency of the jaws to adhere to tissues rapidly, with charcoal and therefore to "break"coagulation.The clamp must be cleaned too often what makes him lose time.Generator & device setup: wanted a compatible generator with monopolar and bipolar standard.Handle ergonomics: very good.Sealing performance: thermal spread - good.Sealing performance: hemostasis - good.Patient status: ni.

• 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: 7217430
• Report Number: 2027111-2018-00029
• Device Sequence Number: 136122
• Product Code: GEI
• UDI-Device Identifier: 00607915127428
• UDI-Public: (01)00607915127428(17)181202(30)01(10)1260870
• 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): 01/24/2018

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: Physician
• Device Expiration Date: 12/02/2018
• Device Model Number: EB030
• Device Catalogue Number: 101223301
• Device Lot Number: 1260870
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2016
• Initial Report FDA Received Date: 01/24/2018
• Patient Sequence Number: 1