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	10/07/2015
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.Procedure minutes - 30.Original: generator and device setup: "bon" sealing performance: "charbonnage; important et rapide, les mors se salissent tres rapidement malgre nettoyage permanent" handle ergonomics: "bon" "probleme important avec les mors, apres fusion les tissus restent colles sur la pince ,le chirurgien trouve cet inconvenient tres ennuyant.Lors dissection nerf recurrent le chir a fusionne vaisseau proche, au moment d'enlever la pince celle ci est reste fixee au tissu et le chir a evite de peu de sectionner le nerf par arrachement.Il a donc considere le dispositif comme dangereux et a utilise la covidien.Il n'a pas avec celle ci rencontre ce probleme de tissus adherents aux mors et n'a pas non plus du nettoyer ceux ci.Pour lui il existe un reel probleme d'adherence des tissus apres fusion, il m'a signale que les premieres generations de covidien avait pose le meme soucis et que ceci avait ete corrige.J'ai donc decide de faire un cer sur le dispositif.Antoine boule est prevenu" sealing performance: "moins rapide que covidien" translation: generator and device setup - "good" sealing performance - ""charring" significant and rapid, the jaws get dirty very quickly despite constant cleaning" handle ergonomics - "good" "important problem with the jaws, after sealing the tissues remain glued on the jaws, the surgeon finds this inconvenient very annoying.When recurrent nerve dissection the surgeon has sealed nearby vessel, at the moment of removing the device it remained fixed to the tissue and the surgeon avoided to cut the nerve by pulling.He therefore considered the device dangerous and used the covidien.He did not have with this one meets this problem of adherents tissues to the jaws and also did not have to clean these ones.For him there is a real problem of adhesion of the tissues after fusion, he indicated to me that the first generations of covidien had the same worries and that this had been corrected.I therefore decided to make a cer on the device." sealing performance: "less fast than covidian" 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: 7217423
• Report Number: 2027111-2018-00028
• Device Sequence Number: 136053
• Product Code: GEI
• UDI-Device Identifier: 00607915127428
• UDI-Public: (01)00607915127428(17)151204(30)01(10)1248405
• 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: 12/04/2015
• Device Model Number: EB030+
• Device Catalogue Number: 101223301
• Device Lot Number: 1248405
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2015
• Initial Report FDA Received Date: 01/24/2018
• Patient Sequence Number: 1