MAUDE Adverse Event Report: MEDTRONIC XOMED INC. VISUALASE; POWERED LASER SURGICAL INSTRUMENT

Model Number	9735560
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The catheter was returned to the manufacturer for analysis.The catheter was found to be fully functional with no problem found.The reported event could not be duplicated by medtronic personnel.H6: fdm b01, fdr c19, and fdc d14 are applicable to the hardware 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.
Event or Problem Description
Medtronic received information regarding a thermal therapy system being used in an unknown procedure.It was reported that the surgeon was having difficulty advancing the catheter through the bolt.The catheter was withdrawn, and it was confirmed that the dura was open using a spinal needle.They tried again and were still met resistance.The surgeon was able to pass the alignment rod through the bolt and the skull easily.The plastic bone anchor was opened to see if the catheter would pass smoothly through it and that also was met with resistance.The surgeon touched the catheter and noticed an area that was not smooth toward the distal end.Another product was opened, and that catheter went through the bolt as usual.There was a reported delay to the procedure of less than 1 hour due to this issue.There was no reported impact on patient outcome.
Additional Manufacturer Narrative
H2: additional information added to b5.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
Additional information was received.It was reported that the procedure being performed was an magnetic resonance imaging (mri) laser ablation.

• Brand Name: VISUALASE
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• Manufacturer (Section G): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• Manufacturer Contact: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 21643979
• Report Number: 1045254-2025-00913
• Device Sequence Number: 15381865
• Product Code: GEX
• UDI-Device Identifier: 00763000416430
• UDI-Public: 00763000416430
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K053087
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2025

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: 9735560
• Device Catalogue Number: 9735560
• Device Lot Number: 0230236606
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2025
• Supplement Date Received by Manufacturer: 03/19/2025
• Initial Report FDA Received Date: 03/19/2025
• Supplement Report FDA Received Date: 04/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/02/2024
• 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: 11 YR
• Patient Sex: Male
• Patient Weight: 34 KG