MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC VISUALASE; POWERED LASER SURGICAL INSTRUMENT

Model Number	9735542
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Medtronic received information regarding a thermal therapy system being used during a soft tissue ablation (neuro) procedure.It was reported that the catheter was misplaced at the first insertion with a competitor system.The trajectory was planned in the competitor system software.It was indicated that it was difficult to answer as to why the trajectory deviated from the plan.It was most likely that the competitor system holder moved during the drilling, or the head position moved with the head clamp.The catheter was placed inaccurately.The target error was too high to start the ablation procedure.New trajectory was chosen at the opposite hemisphere.According to the team post-surgery, the patient had no issues after waking up from anesthesia.A second unnecessary incision and drill hole in the bone was done at the other hemisphere (incision left and right.) there was a reported delay to the procedure of more than 1 hour due to this issue.There was no reported impact on patient outcome.
Additional Manufacturer Narrative
Concomitant medical product: section d information references the main component of the system.Other relevant device(s) are: product id: m016445c001, version: 3.4, h3, h6: no products have been returned to medtronic for analysis.Codes b17, c20, and 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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
H3: the software investigation found that the misplacement was unrelated to a software issue.The software functioned as designed.H6: fdm b01, fdr c19, and fdc d14 are applicable to the software analysis.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: VISUALASE
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 19185561
• Report Number: 1723170-2024-01153
• Device Sequence Number: 20653156
• Product Code: GEX
• UDI-Device Identifier: 00763000402082
• UDI-Public: 00763000402082
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K081656
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 9735542
• Device Catalogue Number: 9735542
• 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: 04/19/2024
• Supplement Date Received by Manufacturer: 06/24/2024
• Initial Report FDA Received Date: 04/25/2024
• Supplement Report FDA Received Date: 07/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/19/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown