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 Consequences Or Impact To Patient (2199)
Date of Event	05/18/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident device is anticipated to return.A follow-up report will be provided upon completion of investigation.
Event or Problem Description
Procedure performed: hemithyroidectomy.Hemithyroidectomy performed in a (b)(6) patient because of goiter.She is not under any special medication (ibuprofeno).She had been under surgery in the past, fallopian tubes were removed.Dr.Starts surgery using eb030 both dissecting and sealing all the time.After around 35 activations in the pedicle area, tissue gets sticked to the jaws.At this point jaws had been cleaned once (even though i insisted on them being cleaned more often).Because of the sticking minor bleeding took place when be tried to remove the jaws attached to the tissue.After this first incident another 10 activations took place.Jaws were cleaned another 3 times but still 3 other sticking episodes took place.Again, when dr.Removed the device jaws from the tissue minor bleedings would happen.At this point dr.Refused to keep on using voyant and he asked for ligasure small jaw to be opened.Paraphrasing the dr."from zero to ten, the confidence that your device gives me is zero, we used ligasure without cleaning it even once to finish the procedure and you could see it never got sticked".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 sealing surfaces and in the blade channel of the device.During functional testing, engineering was able to replicate the sticking that occurred in the event by activating the unit on porcine tissue.Engineering observed that, as eschar built up on the jaws and sealing surfaces of the device, tissue sticking increased.The root cause of the event is blood and eschar buildup.The instructions for use (ifu) warns that "build-up of eschar can negatively affect the sealing and cutting performance.For optimal performance, keep that jaw surfaces clean.Use a gauze pad soaked with sterile water or saline to remove eschar." applied medical will continue to monitor its vigilance system for trends and take appropriate actions as necessary.

• 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: 6595071
• Report Number: 2027111-2017-01815
• Device Sequence Number: 95796
• Product Code: GEI
• UDI-Device Identifier: 00607915127428
• UDI-Public: (01)00607915127428(17)170901(30)01(10)1291087
• Combination Product (Y/N): N
• Initial Reporter Country: ES
• 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): 07/05/2017

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: 08/28/2017
• Device Model Number: EB030
• Device Catalogue Number: 101223301
• Device Lot Number: 1291086
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2017
• Supplement Date Received by Manufacturer: 05/18/2017
• Initial Report FDA Received Date: 05/26/2017
• Supplement Report FDA Received Date: 07/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1