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

Model Number	EB030
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/19/2017
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: parotidectomy.During the procedure, 1 hour after the start of the procedure, the button operating the knife has broken, disengaged from the spring actuating the knife, the blade came out while the jaws were open.This incident made impossible the use of the device, another voyant device was given to the surgeon.There was no consequence on the patient.The device has been preserved and can be collected at the pharmacy.Additional information received from the sales rep on 02 october 2017: the surgeon uses regularly our eb030 since more than a year and i did not notice any modification in the way that he had to use it.The surgeon respects the applied medical recommendations and does never seal vessels with diameter greater than 7mm.I did not observe any torque being applied when the surgeon positioned the device on tissues.The surgeon was manipulating vessels nearby the parotid.The size of the vessels is unknown.Patient status: no consequence on the patient.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant"s experience in which "the blade came out while the jaws were open." engineering observed that the blade had disengaged from the blade link, leaving the blade exposed in the forward position.Based on the condition of the returned unit, the reported event was caused by handle separation.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.Applied medical continuously seeks to improve the form, function and ease of use of its products.As part of this process, applied medical is currently researching possible device enhancements intended to further minimize the potential for this type of event to occur.

• 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 ; NL 92688
• MDR Report Key: 6925715
• Report Number: 2027111-2017-02054
• Device Sequence Number: 461830
• Product Code: GEI
• UDI-Device Identifier: 00607915127428
• UDI-Public: (01)00607915127428(17)171013(30)01(10)1294238
• 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,Followup
• Report Date (Section B): 10/06/2017

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: 10/13/2017
• Device Model Number: EB030
• Device Catalogue Number: 101223301
• Device Lot Number: 1294238
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2017
• Supplement Date Received by Manufacturer: 09/19/2017
• Initial Report FDA Received Date: 10/06/2017
• Supplement Report FDA Received Date: 10/31/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1