MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) VISUALASE COOLED LASER APPLICATOR SYSTEM; POWERED LASER SURGICAL INSTRUMENT

Catalog Number	9735560
Medical Device Problem Codes	Mechanical Problem (1384); Device Markings/Labelling Problem (2911)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	12/08/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information was unavailable from the site.No parts have been received by the manufacturer for evaluation.Part not returned for analysis.
Event or Problem Description
A site representative reported that, while in a neuro soft tissue ablation, the cooling catheter was measuring half a millimeter off from the expected value.The measurement was confirmed via a ruler.There was no reported delay to the procedure due to this issue.There was no impact on patient outcome.No additional information was provided.
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: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• MDR Report Key: 7169111
• Report Number: 1723170-2018-00090
• Device Sequence Number: 13932744
• Product Code: GEX
• UDI-Device Identifier: 00643169611993
• UDI-Public: 00643169611993
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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,Followup
• Report Date (Section B): 04/30/2019

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: Physician
• Device Catalogue Number: 9735560
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2017
• Supplement Date Received by Manufacturer: 12/08/2017
• Initial Report FDA Received Date: 01/05/2018
• Supplement Report FDA Received Date: 04/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1