MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC AQUAMANTYS 2.3 BIPOLAR SEALER; ELECTROSURGICAL, CUTTING & COAGULATION & ACCES

Model Number	23-113-1
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: complaint was unconfirmed.Upon receiving the device, it looked to be used with the tubing and cord cut.The device was decontaminated and then tested per wi.Upon visual inspection, the handpiece tubing and cord were cut.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 manufacturer representative regarding a handpiece.It was reported that the handpiece button was not working.A new handpiece was brought in, and it functioned as designed.Additional information was received.It was reported that the incident happened at the start of the case.Patient was present and the case was delayed slightly to replace with new handpiece and it was reported that the procedure performed at the time of event occurred was a spine case.

• Brand Name: AQUAMANTYS 2.3 BIPOLAR SEALER
• 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: 22963556
• Report Number: 1723170-2025-03133
• Device Sequence Number: 12863156
• Product Code: GEI
• UDI-Device Identifier: 00763000280895
• UDI-Public: (01)00763000280895(17)290915(10)PHI1624K
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K052859
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/04/2025

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: PHI1624K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2025
• Initial Report FDA Received Date: 09/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/16/2024
• 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: 68 YR
• Patient Sex: Male