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

Model Number	7
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/06/2017
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: lavh."at activation 20 the surgeon went to grasp the tissue and the voyant fine fusion handpiece snapped.When i spoke to the surgeon does not believe he used a lot of force to get it to snap at the hinge.All pieces recovered and blade stayed in place." additional information received from territory manager associate on (b)(6) 2017: the blade was not exposed.There was no bleeding from the snapping as it snapped while the surgeon was grasping the tissue, no energy had been applied and the jaws had not been locked in place.The tissue being grasped was a section of the cervix where there was tumor.No part of the device fell into the patient's abdomen.The spring did come off but landed on the floor and the rest of the handpiece was in the surgeons hand.This section was already open as this stage was the end stage of an lavh.No patient damage occurred.Patient status: no patient injury or illness associated with the complaint.
Additional Manufacturer Narrative
Investigation summary: the event unit was returned for evaluation.Upon visual inspection, eschar and blood buildup was observed on the sealing surfaces of the jaws of the device and confirmed that the handle had separated.Engineering confirmed that all components of the device were returned along with the device.Functional testing was not performed as the device was returned non-functional.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.
Event or Problem Description
Additional info received from applied team member, 31st july: "as far as i am aware the tissue being grasped at the time was the vaginal cuff where there shouldn't have been any tumour due to the margins taken during the lavh.I am fairly certain it was soft tissue.".

• 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: 6638961
• Report Number: 2027111-2017-01837
• Device Sequence Number: 613333
• Product Code: GEI
• UDI-Device Identifier: 00607915127428
• UDI-Public: (01)00607915127428(17)170804(30)01(10)1288751
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: 7
• 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): 08/10/2017

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: 08/04/2017
• Device Model Number: 7
• Device Catalogue Number: 7
• Device Lot Number: 1288751
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2017
• Supplement Date Received by Manufacturer: 06/06/2017
• Initial Report FDA Received Date: 06/13/2017
• Supplement Report FDA Received Date: 08/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1