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

Model Number	8
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/06/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Ra has just received the incident device and has been assigned to engineering for evaluation.A follow-up report will be sent upon completion of investigation.
Event or Problem Description
Procedure performed unknown- after 10 minutes the device wouldn't cut anymore.To finish the procedure the device has been replaced by another one with a different lot number and everything went fine.Additional information received from sales rep on 24 march 2017: standard tissue, section of the parameter during a vaginal hysterectomy.He experienced a small resistance when he tried to activate the blade.There was no separation but he noticed that the handle didn't seemed to be well in the axis, even to launch a fusion cycle he told me that he had to be careful to be able to make the contact between the two parts.Type of intervention: na.Patient status: no patient injury or illness occurred associated with the complaint event.
Additional Manufacturer Narrative
Investigation summary: the event unit was returned for investigation.Upon inspection, engineering observed that the blade remained in the extended position in the jaws and the handles had separated slightly.Engineering attempted to activate the device trigger and observed that the blade had become disconnected from the blade link.Engineering was able to re-connect the blade to the blade link and thereafter they noted normal cutting function.The root cause of the event is due to component separation.Applied medical has opened a corrective and preventative action report to further elevate and track this investigation and implement appropriate corrective actions, where applicable, to mitigate this type of event.

• 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: 6474309
• Report Number: 2027111-2017-01672
• Device Sequence Number: 13598923
• Product Code: GEI
• UDI-Device Identifier: 00607915127428
• UDI-Public: (01)00607915127428(17)190328(30)01(10)1267225
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: 8
• 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): 05/22/2017

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: 03/28/2019
• Device Model Number: 8
• Device Catalogue Number: 8
• Device Lot Number: 1267225
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/07/2017
• Supplement Report FDA Received Date: 05/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1