MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. AQUAMANTYS¿; ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES

Model Number	23-113-1
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During the case, it was discovered that the aquamantys tubing had a hole in the line.The aquamantys was dripping onto the floor and the irrigation from the bag had been used to irrigate an integra patch for implantation.The tubing was not saved after the procedure and the or manager submitted a ticket for biomed dept investigation of the aquamantys machine as the hole in tubing was within the machine itself - pending feedback from biomed dept.At this time.

• Brand Name: AQUAMANTYS¿
• Common Device Name: ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC.; 200 medtronic drive; lafayette CO 80026
• MDR Report Key: 22518725
• Report Number: 22518725
• Device Sequence Number: 18449434
• Product Code: GEI
• UDI-Device Identifier: 00763000738556
• UDI-Public: (01)00763000738556
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/11/2025
• Report Date (Section F): 07/11/2025

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 Model Number: 23-113-1
• Device Catalogue Number: 23-113-1
• Device Lot Number: PHC0325J
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 07/16/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/16/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 35 YR
• Patient Sex: Female
• Patient Weight: 63 KG
• Date Report Sent to FDA: 07/11/2025