MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES EB011, VOYANT 5MM FUSION, 44CM 6/BX; GEI

Model Number	22
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/17/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit was returned for evaluation.Upon visual inspection, engineering noted blood and eschar on the jaws and in the blade channel.Engineering was able to confirm the customer experience.A review of the manufacturing records for this lot confirmed that the product passed all manufacturing and quality inspections.The root cause of poor cutting performance was a dull blade.Engineering was unable to determine when the blade was dulled.Applied medical will continue to monitor its vigilance system for trends and take appropriate actions as necessary.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.In accordance to 21 cfr 803.56, if additional information is obtained which was not known or was not available when this report was submitted, then a supplemental report will be submitted to the fda.
Event or Problem Description
Gastric sleeve - "while using the voyant 5mm fusion in a gastric sleeve dr.(b)(6) was having to regrasp and reactivate the blade to get a complete cut as just firing energy and and activating the blade was leaving thin tissue strands across about 30% of his initial seals.Seal strenght did not appear to be impacted." patient status - patient status not impacted by experience.

• Brand Name: EB011, VOYANT 5MM FUSION, 44CM 6/BX
• Common Device Name: GEI
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 6378802
• Report Number: 2027111-2017-01336
• Device Sequence Number: 16376835
• Product Code: GEI
• UDI-Device Identifier: 00607915134754
• UDI-Public: (01)00607915134754(17)161221(30)01(10)1249352
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: 22
• 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): 03/03/2017

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: 12/21/2016
• Device Model Number: 22
• Device Catalogue Number: 22
• Device Lot Number: 1249352
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2015
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2015
• Initial Report FDA Received Date: 03/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1