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

Model Number	9735560
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No parts have been received by the manufacturer for evaluation.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a thermal therapy system being used during a soft neuro tissue ablation.It was reported that the tubing for the system was clogged and leaked prior to the ablation beginning.When checking the lines, the center of the line's connector was clogged and leaking between the two ends of the line.Replacing the line restored functionality.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.

• Brand Name: VISUALASE
• Common Device Name: LASER INSTRUMENT, SURGICAL, POWERED
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 11244122
• Report Number: 1723170-2021-00235
• Device Sequence Number: 3616819
• Product Code: GEX
• UDI-Device Identifier: 00763000218188
• UDI-Public: 00763000218188
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K053087
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/28/2021

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 Expiration Date: 11/04/2022
• Device Model Number: 9735560
• Device Catalogue Number: 9735560
• Device Lot Number: 0221113986
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2021
• Initial Report FDA Received Date: 01/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 22 YR
• Patient Weight: 107