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

Model Number	EB010
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Mechanical Jam (2983)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit was returned for evaluation.The device was returned in the latched position with the blade partially extended in the jaws.During functional testing, engineering was unable to activate the blade, which confirmed that the device was unable to cut tissue.After disassembly of the device, engineering observed that the blade pusher, an internal component of the device that facilitates movement of the blade, was broken.Based on the condition of the returned unit, it is likely that the reported event was caused by the broken blade pusher.However, the root cause of the broken blade pusher could not be determined.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.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 reflects both the initial and final report.
Event or Problem Description
Procedure performed: lavh.The device worked fine in the beginning.It gradually started to stop cutting, but was still able to fuse.Rep was not in surgery at the time, but spoke to doctor after the surgery and went over the process, including cleaning of jaws.Doctor was aware as he has used the device many times.He did say that the device felt funny out of the box.Type of tissue being cut when poor cutting performance was noticed is unknown.Where along the jaw was the blade not cutting? it wasn't cutting at all.Patient status: fine.

• 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: 7945201
• Report Number: 2027111-2018-00377
• Device Sequence Number: 930503
• Product Code: GEI
• UDI-Device Identifier: 00607915117856
• UDI-Public: (01)00607915117856(17)191017(30)01(10)1323107
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K141288
• 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): 10/08/2018

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: 10/17/2019
• Device Model Number: EB010
• Device Catalogue Number: 101462801
• Device Lot Number: 1323107
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2018
• Initial Report FDA Received Date: 10/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1