MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES EB011, VOYANT 5MM FUSION 44CM, 6/BX; GEI

Model Number	EB011
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/25/2017
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 the investigation.
Event or Problem Description
Procedure performed: sleeve gastrectomy.Device stayed blocked in close position at the third sealing.The surgeon was able to remove the device from the tissues without difficulty and took another device to complete the procedure.La pince est restee bloquee en position fermee à la troisieme coagulation.Le chirurgien a pu retirer le dispositif des tissus sans difficulté puis a repris un autre dispositif pour finir son intervention.Additional information received from rep on 3 may 2017: the jaws of the device could not be reopened.The surgeon pulled it out, thereby tearing the tissue, and realized hemostasis with the second device.Additional information received from sales rep on 4 may 2017: the informations given by the hospital are the good ones.Product code eb011 lot 1282637.Date of event (b)(6) 2017.Type of intervention: unknown.Patient status: no patient injury or illness occurred associated with the complaint event.
Additional Manufacturer Narrative
Investigation summary: the event unit was returned for evaluation in the latched position.During visual inspection, engineering observed blood and eschar on the outside of the jaws and in the blade channel of the device.During functional testing, engineering disassembled the device and observed that a component located at the bottom of the trigger, that allows the trigger to be engaged to the handle, was bent.Engineering replaced the bent component with a conforming component and found that the trigger was able to engage and disengage as intended.The root cause of the event is a bent component within the trigger of the handle.Applied medical has opened a corrective and preventative action report to further elevate and track this investigation and implement corrective actions, where applicable, to mitigate this type of event.

• Brand Name: EB011, VOYANT 5MM FUSION 44CM, 6/BX
• Common Device Name: GEI
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 6582004
• Report Number: 2027111-2017-01807
• Device Sequence Number: 19152108
• Product Code: GEI
• UDI-Device Identifier: 00607915134754
• UDI-Public: (01)00607915134754(17)180425(30)01(10)1282637
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Followup
• Report Date (Section B): 06/21/2017

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: 04/28/2018
• Device Model Number: EB011
• Device Catalogue Number: 101427001
• Device Lot Number: 1282637
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/22/2017
• Supplement Report FDA Received Date: 06/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1