MAUDE Adverse Event Report: MEDTRONIC XOMED 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	02/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The tubing set was returned to the manufacturer for evaluation.Visual inspection found no indications of damages that would cause a leak.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 saline tubing leaked after being removed from the packing upon priming.Tubing was subsequently replaced to continue with the procedure.There was a reported delay to the procedure of two minutes 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 XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• MDR Report Key: 11372730
• Report Number: 1045254-2021-00079
• Device Sequence Number: 3742788
• Product Code: GEX
• UDI-Device Identifier: 00763000218188
• UDI-Public: 00763000218188
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 02/24/2021

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: 09/02/2022
• Device Model Number: 9735560
• Device Catalogue Number: 9735560
• Device Lot Number: 0220704361
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2021
• Initial Report FDA Received Date: 02/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 30 MO
• Patient Weight: 15