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

Model Number	9735560
Medical Device Problem Codes	Mechanical Problem (1384); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/22/2019
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 being used for a laser ablation procedure.It was reported that in tra-operatively, it was noted the cooling tubing appeared to have too much glue and saline would not flow.The site swapped to another disposable that was available.There was no impact on the case and they proceeded as normal with less than five minutes delay.The extension tubing was disposed.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: VISUALASE COOLED LASER APPLICATOR SYSTEM
• Common Device Name: LASER INSTRUMENT, SURGICAL, POWERED
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• MDR Report Key: 8568994
• Report Number: 1045254-2019-00221
• Device Sequence Number: 16577201
• Product Code: GEX
• UDI-Device Identifier: 00643169933385
• UDI-Public: 00643169933385
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2019

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: 10/15/2020
• Device Model Number: 9735560
• Device Catalogue Number: 9735560
• Device Lot Number: 0216415496
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/22/2019
• Supplement Date Received by Manufacturer: 05/06/2019
• Initial Report FDA Received Date: 05/01/2019
• Supplement Report FDA Received Date: 05/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 6 YR
• Patient Weight: 18