MAUDE Adverse Event Report: MEDTRONIC ADVANCED ENERGY (SALIENT) AQUAMANTYS MBS W/ LIGHT; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	23-301-1
Medical Device Problem Codes	Smoking (1585); Obstruction of Flow (2423)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a healthcare professional (hcp) regarding a generator and handpiece uses in an unknown procedure.It was reported that when initially activated the device emitted a loud popping sound and began smoking in the surgeon¿s hands.It was noted this happened with 2 devices, a third device was opened but the physician declined to activate the device due to the performance of the other two device.Additional information received from a healthcare professional.It was reported that the incident was investigated by local manufacturer representative (rep), who ascertained it was the result of operator error.The hcp noted the product did not come in contact with the patient at any time and the effected was taken by the vender rep.Additional information from the manufacturer representative (rep) reported the event happened on (b)(6) 2019 and they were made aware that same day.The rep noted they met with the account and the surgeon on (b)(6), the pump on the generator malfunctioned and was no longer providing saline to the tip of the device.The rep noted the generator had been removed.
Additional Manufacturer Narrative
(b)(4).Review of this mdr and/or additional information received shows that there is no information to reasonably suggest that the device in this report may have caused or contributed to a death or serious injury or that the device in this report has malfunctioned.Therefore, this event did not and does not meet the reporting requirements stipulated in 21 cfr 803.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information was received from manufacturer representative (rep) reported the pump on the generator was not supplying saline."the" stated the handpieces were activated to make sure they worked before using them on the patient.The rep noted he did not believe it was operator error, but rather the pump being broken and not supplying saline.The rep clarified there was no "smoke" but steam.It was noted the generator was still at the facility not in use.

• Brand Name: AQUAMANTYS MBS W/ LIGHT
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MEDTRONIC ADVANCED ENERGY (SALIENT); 180 international drive; portsmouth NH 03801
• MDR Report Key: 8642702
• Report Number: 1226420-2019-00101
• Device Sequence Number: 2567108
• Product Code: GEI
• UDI-Device Identifier: 00763000047450
• UDI-Public: 00763000047450
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K073495
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/30/2019

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: Health Professional
• Device Expiration Date: 01/29/2020
• Device Model Number: 23-301-1
• Device Catalogue Number: 23-301-1
• Device Lot Number: PHG318E0
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2019
• Supplement Date Received by Manufacturer: 05/29/2019
• Initial Report FDA Received Date: 05/24/2019
• Supplement Report FDA Received Date: 05/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1