MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC AQUAMANTYS MBS W/ LIGHT; ELECTROSURGICAL, CUTTING & COAGULATION & ACCES

Model Number	23-301-1
Medical Device Problem Codes	Failure to Prime (1492); Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: cannot confirm complaint.Upon receiving the device the tubing was cut and unable to conduct analysis.The device was decontaminated.H6: codes b01, c07 d02 are applicable.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 a healthcare provider regarding a generator.It was reported that during a surgical procedure, the handpiece failed to prime and there was no saline flow in tubing.Initially tubing was placed into the pump segment and the prime button was pressed.The pump segment rollers were audibly turning inside but there was no fluid movement.The prime feature was stopped and the tubing was removed from the pump.Troubleshooting methods were performed with tubing removed and prime button pressed briefly with the pump segment open to visually inspect movement of the rollers (no issue noted), the iv bag was squeezed but no fluid was passing through the tubing, a new 1000ml bag of saline was spiked and the drip chamber was squeezed but did not move fluid down the tubing, a final attempt was made by placing the tubing back into the pump segment but the tubing would not prime or deliver fluid to the tip of the device.Failed to resole the issue after multiple attempts.A new handpiece was delivered to the sterile field and then connected to the aex generator, it worked without issue.No reported impact on patient.Additional information was received.It was reported that the surgery performed at the time of event occurred was an anterolateral approach to a total hip arthroplasty and there was a minor surgical delay of 3 minutes.

• Brand Name: AQUAMANTYS MBS W/ LIGHT
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCES
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 200 medtronic drive; lafayette 80026
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC; 200 medtronic drive; lafayette 80026
• Manufacturer Contact: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 22892147
• Report Number: 1723170-2025-03068
• Device Sequence Number: 5802560
• Product Code: GEI
• UDI-Device Identifier: 00763000280918
• UDI-Public: (01)00763000280918(17)280309(10)PHC1025C(20)01
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 08/26/2025

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: 23-301-1
• Device Catalogue Number: 23-301-1
• Device Lot Number: PHC1025C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2025
• Initial Report FDA Received Date: 08/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/10/2025
• 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
• Patient Age: 54 YR
• Patient Sex: Male
• Patient Weight: 104 KG