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

Model Number	9735559
Medical Device Problem Codes	Thermal Decomposition of Device (1071); Mechanical Problem (1384); Biocompatibility (2886)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3, h6: no products were 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.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 during a soft tissue ablation (neuro) procedure.It was reported that after running the first post-ablation scan, noticed there was some saline pooled around catheter #1.After the catheter was removed from the patient, the surgeon and surgery consultant examined it and ran a syringe of saline through it to see if they could identify the leak.They observed a small leak around 3cm back from the distal tip that corresponded to a bit of discoloration (possibly char) on the catheter.Nothing was observed in the live ablation session on the tmaps or dmaps that would have indicated a leak, but after reviewing the tmap images in the review tool, it looked like the leak occurred right at the end of the final ablation for catheter #1.There was no reported delay to the procedure.There was no reported impact to the patient.
Additional Manufacturer Narrative
A010101: leak inside patient's anatomy a1006: discoloration, possibly char h2, b5: event details have been updated.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 leak occurred inside the patient's anatomy.
Additional Manufacturer Narrative
H2, correction: d4 udi updated.H3: the catheter was returned to the manufacturer for analysis.Analysis found that the returned catheter was bent in three places near the tip.As reported, there was a spot that appeared to have charring damage.It was not possible to confirm the leak.Analysis found that the reported event was related to a mechanical issue.H6: fdm b01, fdr c07, and fdc d02 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.

• 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: 22158813
• Report Number: 1045254-2025-01470
• Device Sequence Number: 7484680
• Product Code: GEX
• UDI-Device Identifier: 00763000416423
• UDI-Public: (01)00763000416423(17)261205(10)0230266251
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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,Followup
• Report Date (Section B): 08/01/2025

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: 9735559
• Device Catalogue Number: 9735559
• Device Lot Number: 0230266251
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2025
• Supplement Date Received by Manufacturer: 06/06/2025; 07/23/2025
• Initial Report FDA Received Date: 06/06/2025
• Supplement Report FDA Received Date: 06/17/2025; 08/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/05/2024
• 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: Initial
• Patient Sequence Number: 1
• Patient Age: 16 YR
• Patient Sex: Male
• Patient Weight: 81 KG