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

Model Number	23-301-1
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	03/08/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No parts have been received by the manufacturer for evaluation.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Information was received from healthcare provider (hcp) via a manufacturer representative regarding a handpiece.It was reported that during a procedure the patient had superficial burns from hot saline.The surgeon noted that the burn on the left imf from the handpiece had healed in 2/3 but not in 1/3 and would require a surgical scar revision at a later date.It was also noted that the issue was not with the product but was user error.
Event or Problem Description
Additional information was received.It was reported that the issue occurred during a breast lift procedure and there was no delay.
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• 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
• Manufacturer (Section G): MEDTRONIC ADVANCED ENERGY (SALIENT); 180 international drive; portsmouth NH 03801
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 19044765
• Report Number: 1226420-2024-00018
• Device Sequence Number: 12568545
• Product Code: GEI
• UDI-Device Identifier: 00763000280918
• UDI-Public: 00763000280918
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K073495
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/28/2026
• Device Model Number: 23-301-1
• Device Catalogue Number: 23-301-1
• Device Lot Number: PHH2923B
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2024
• Supplement Date Received by Manufacturer: 04/14/2024
• Initial Report FDA Received Date: 04/04/2024
• Supplement Report FDA Received Date: 04/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/29/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female