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

Model Number	EB030+
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/09/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being filed as a result of a re-review of applied medical complaints received between june 1, 2014 and may 31, 2016.This retrospective review was associated with a quality management system (qms) compliance action plan developed and presented to fda to address an april 10, 2015 warning letter.Applied medical has revised its mdr reporting criteria to be more conservative and has improved complaint handling and mdr reporting processes.The reviews ensured that recent 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.Investigation summary: the event unit was returned for evaluation.Upon inspection, engineering analyzed the device activation logs that were extracted from a microchip in the device plug and found 31 activations.Of these, six were "reactivate switch released" entries, which indicate premature release of the fuse button.Premature release of the fuse button will result in an alarm by the generator and interruption of energy output; a safety feature by design.During functional testing, engineering tested the cutting performance of the device on porcine mesentery and concluded that the device performed to specifications and successfully transected tissue on all activations.Engineering was able to replicate the "reactivate switch released" alarms by prematurely releasing the handles/fuse buttons.Poor cutting performance was replicated by attempting to activate the blade with the handles not fully closed.Upon further inspection, engineering found that the front conductive stop was positioned out of specification during use of the device.This occurrence led to an insufficient gap between the jaws, which will result in an alarm by the generator and interruption of energy output.The root cause of the "check device" alarms is due to an insufficient jaw gap.The likely root cause of poor cutting is due to activation of the blade prior to full closer of the device handles.Applied medical will monitor its vigilance systems for trends and take appropriate actions as necessary.
Event or Problem Description
Total thyroidectomy "total of three devices were opened.First device had several check device alarms and was not cutting properly.Second device was opened, plugged into generator, and would not activate.Third device had several check device alarms on thin tissue and did not seal tissue properly, during the seal cycle, the tissue fell out of the jaws incompletely on occasion." patient status- no patient injury.

• 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: 6520592
• Report Number: 2027111-2017-01742
• Device Sequence Number: 16327821
• Product Code: GEI
• UDI-Device Identifier: 00607915127428
• UDI-Public: (01)00607915127428(17)151224(30)01(10)1249676
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/25/2017

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: 12/24/2015
• Device Model Number: EB030+
• Device Catalogue Number: 101470863
• Device Lot Number: 1249676
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2015
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2015
• Initial Report FDA Received Date: 04/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1