MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC AQUAMANTYS ENDO DBS 8.7; ELECTROSURGICAL, CUTTING & COAGULATION & ACCES

Model Number	23-317-1
Medical Device Problem Code	No Device Output (1435)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	05/21/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(h3,h6): no parts have been received by the manufacturer for evaluation.Codes b17, c20 <(>&<)> d15 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 handpiece.It was reported that during a case, when site opened the package and used the handpiece, it experienced no output.Initially, it was suspected that the host was faulty, so used with another host, but still device had no output.Site tried handpiece with two different machines but issue still persisted.So it was replaced with a new handpiece.Additional information was received.It was reported that there was a serious harm associated with patient.Failed to use the device which lead to increase bleeding during surgery and required blood transfusion.The surgical procedure performed during the event occurred was right hemi liver resection and there was a surgical delay of less than one hour.

• Brand Name: AQUAMANTYS ENDO DBS 8.7
• 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: 22202794
• Report Number: 1723170-2025-02315
• Device Sequence Number: 17831585
• Product Code: GEI
• UDI-Device Identifier: 00763000280956
• UDI-Public: 00763000280956
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/13/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 23-317-1
• Device Catalogue Number: 23-317-1
• Device Lot Number: PHJ1223C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2025
• Initial Report FDA Received Date: 06/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/12/2023
• 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: Life Threatening
• Patient Age: 50 YR
• Patient Sex: Male