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

Model Number	EB030
Medical Device Problem Codes	Sticking (1597); Failure to Cut (2587)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Ra has received the incident device and the product has been assigned to engineering for evaluation.A follow-up report will be sent upon completion of the investigation.
Event or Problem Description
Hemi thyroidectomy - "start procedure; skin was incised with knife blade.Dissection of subcutaneous tissue was done with a needle electrode until the thyreoid gland was visible.Blunt dissection was performed with a dissector to free up the blood vessels and small tissue bundels.Voyant was used to seal and dissect.During the first 10 activations sealing and dissection of the seal was normal.After every 2 to 3 activations the jaws were cleaned with a wet gauze because of eschar builup.After 10 activations the surgeon and scrub nurse started to notice that tissue began to stuck to the jaws.They had to use a foreceps to get the sealed tissue from the jaws.They started cleaning the jaws after every activation.Stickiness kept happening.It was also noticed that the knife blade didn't cut the seal completely.Meaning that they had to use a scissor to devide some remaning sealparts.It was noticed that the color of the jaws of the voyant changed, became more grey/black after 10/15 activations.The operating team decided to use standard bipolar or using scissors instead of using voyant because this was less time consuming." patient status - no patient injury or illness occur associated with the complaint event.
Additional Manufacturer Narrative
Investigation summary: the event unit was returned for evaluation.Upon visual inspection, engineering observed blood and eschar buildup on the jaws.During functional testing, engineering was able to replicate the sticking that occurred during the event by activating the device on porcine tissue.Engineering observed that, as eschar built up on the jaws and sealing surfaces of the device, tissue sticking increased.Upon further inspection, engineering found that the conductive stops, insulated components located at the distal and proximal ends of the static jaw, sunk during use of the device, leading to an insufficient gap between the jaws.This can result in increased tissue adherence.Upon further inspection, engineering tested the cutting performance of the device on porcine tissue and concluded that the device performed to specifications and successfully transected tissue on all activations.As such, engineering was unable to replicate "failure to cut" and determined that the blade functioned as intended.Engineering also compared the color of the sealing surfaces of the returned device to a known conforming device and confirmed a slight discoloration.The discoloration may be due to the environment it was used in, type of tissue it is used to seal on, or conductive fluids surrounding the jaws as it is used to seal.The discoloration is not indicative of device performance.The root cause of tissue adherence observed during the event is due to the movement of the conductive stop.Engineering was unable to determine a root cause for "failure to cut" as they were unable to replicate the incident.Applied medical recently implemented device enhancements intended to further minimize the potential for tissue sticking.

• 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: 6437719
• Report Number: 2027111-2017-01636
• Device Sequence Number: 550698
• Product Code: GEI
• UDI-Device Identifier: 00607915127428
• UDI-Public: (01)00607915127428(17)170807(30)01(10)1289553
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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): 05/22/2017

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: Other
• Device Expiration Date: 08/07/2017
• Device Model Number: EB030
• Device Catalogue Number: 101223301
• Device Lot Number: 1289553
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/27/2017
• Supplement Report FDA Received Date: 05/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1