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

Model Number	EB030
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/28/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Ra has received the incident device and the product has been assigned to engineering for evaluation.A follow-up report will be sent upon completion of the investigation.
Event or Problem Description
Mastectomy with axillary node - "during use of the voyant device, the scissors did not cut or cut less, despite regular cleaning of the device." original:lors de l'utilisation de la pince thermofusion voyant, le ciseau ne coupait pas ou peu, malgré le nettoyage de la pince.Additional information received from the sales rep on 27 march 2017: "despite the bad quality of cutting she used the eb030 hand piece during all the procedure she just used a scissors to have a good cutting => the time procedure was longer.All type of tissue (fat, muscles, vascular.) were cut during the event.She noticed the bad cutting quality from the beginning of the procedure." 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.There was no blood or eschar build up on the jaws or in the blade channel.Engineering activated the device on porcine tissue and the device performed to specifications initially.However, after several activations, engineering was able to replicate the event of poor cutting performance.Upon cleaning the blade channel and jaws of the device, cutting performance improved and the tissue was transected successfully along the blade channel.Similar events have shown that eschar buildup inside the blade channel of the device can negatively affect cutting performance.The instructions for use (ifu) states "warning: build-up of eschar can negatively affect the sealing and cutting performance." and "for optimal performance, keep the jaw surfaces clean.Use a gauze pad soaked with sterile water or saline to remove eschar".Applied medical will continue to monitor its vigilance system for trends and take appropriate actions as necessary to ensure the performance and safety of the products.

• 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: 6448036
• Report Number: 2027111-2017-01654
• Device Sequence Number: 1502951
• Product Code: GEI
• UDI-Device Identifier: 00607915127428
• UDI-Public: (01)00607915127428(17)170608(30)01(10)1279015
• 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): 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: 06/08/2017
• Device Model Number: EB030
• Device Catalogue Number: 101223301
• Device Lot Number: 1279015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/30/2017
• 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