MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES EB010, VOYANT 5MM FUSION 37CM, 6/BX; GEI

Model Number	EB010
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/15/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: the event unit was not returned to applied medical for evaluation, and the lot number was not provided.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 (b)(6) 2014 - (b)(6) 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: adnexa removal / salpingo-oophor.Incident description: "has some doubts about the hemostasis of the voyant.Said he performed a tlh on the 14th and that there was a lot of bloodloss.During this procedure, there was at one point a bleeding as well.It was hard to conclude whether it was the cause of the device." patient status: ni.

• Brand Name: EB010, VOYANT 5MM FUSION 37CM, 6/BX
• Common Device Name: GEI
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 7272162
• Report Number: 2027111-2018-00074
• Device Sequence Number: 11224434
• Product Code: GEI
• UDI-Device Identifier: 00607915117856
• UDI-Public: (01)00607915117856(17)160107(30)01(10)1250086
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K141288
• 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): 02/14/2018

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: Health Professional
• Device Expiration Date: 01/07/2016
• Device Model Number: EB010
• Device Catalogue Number: 101462801
• Device Lot Number: 1250086
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2015
• Initial Report FDA Received Date: 02/14/2018
• Patient Sequence Number: 1