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

Model Number	9735559
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/18/2019
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.It was reported that while conducting preclinical data collection, it was not possible to get saline through the tubing.It was found that the issue was with the portion that connected to the iv bag.Another pump tubing set was opened and they were able to get saline flow.There was no patient present when this issue was identified.

• 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: 8821570
• Report Number: 1045254-2019-00355
• Device Sequence Number: 2348713
• Product Code: GEX
• UDI-Device Identifier: 00763000218171
• UDI-Public: 00763000218171
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/24/2019

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: 04/24/2021
• Device Model Number: 9735559
• Device Catalogue Number: 9735559
• Device Lot Number: 0217582588
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2019
• Initial Report FDA Received Date: 07/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1