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

Model Number	1
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/23/2017
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: gastrektomie-sleeve.Original: in laufe der op nahm die energieleistung unseres systems ab, so dass auch kleinlumige gefässe nicht kompllett versiegelt werden konnten.Im weiteren verlauf der operation musste dr.Herrfuth auf ein ettbewerbsprodukt intraoperativ umstellen.Translation by regional sales manager: in the course of the operation, the energy output of our system decreased, so that even small-lumen vessels could not be completely sealed.In the further course of the operation dr.Herrfuth had to switch to a competition product intraoperatively.Additional information received from rep on 2jun2017: there were hemostasis issues; shortly after the sealing cycle was completed, the blood vessels started bleeding again.The user noticed the decrease in rf-output, because at the beginning of the surgery, this problem didn't exist yet.The generator did emit the tone that the seal cycle was complete, and there were no alarms.Type of intervention: n/a.Patient status: no patient injury occurred.
Additional Manufacturer Narrative
Investigation summary: the event unit was returned for evaluation.During functional testing, engineering confirmed that the device functioned as intended and met current specifications.Although the root cause of the event could not be determined, 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.

• 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: 6638944
• Report Number: 2027111-2017-01841
• Device Sequence Number: 16146518
• Product Code: GEI
• UDI-Device Identifier: 00607915134754
• UDI-Public: (01)00607915134754(17)180830(30)01(10)1289947
• Combination Product (Y/N): N
• PMA/510(K) Number: 1
• 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): 07/19/2017

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: 08/30/2018
• Device Model Number: 1
• Device Catalogue Number: 1
• Device Lot Number: 1289947
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2017
• Supplement Date Received by Manufacturer: 05/23/2017
• Initial Report FDA Received Date: 06/13/2017
• Supplement Report FDA Received Date: 07/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1