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

Model Number	9735542
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The tubing was returned to the manufacturer for evaluation.Analysis found that manipulation of the tubing at the female luer connection point resulted in a leak.The hardware investigation found that the reported event was related to a hardware issue.This issue was documented in a medtronic navigation hardware anomaly tracking database.Concomitant medical products: other relevant device(s) are: product id: 9735560, serial/lot #: (b)(4), ubd: 15-feb-2024, udi#: (b)(4).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 procedure.It was reported that the tubing of the thermal therapy system leaked.There was a reported delay to the procedure of five minutes due to this issue.There was no reported impact on patient outcome.

• 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: 14453120
• Report Number: 1723170-2022-00769
• Device Sequence Number: 6355267
• Product Code: GEX
• UDI-Device Identifier: 00763000402082
• UDI-Public: 00763000402082
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K081656
• 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
• Report Date (Section B): 05/19/2022

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: 9735542
• Device Catalogue Number: 9735542
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2022
• Initial Report FDA Received Date: 05/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/29/2021
• 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
• Patient Age: 54 YR
• Patient Sex: Male
• Patient Weight: 88 KG