MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) SYSTEM 9735542 15W VISUALASE; POWERED LASER SURGICAL INSTRUMENT

Catalog Number	9735542
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Codes	Swelling (2091); Iatrogenic Source (2498)
Date of Event	03/02/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A subsequent surgery was covered by a field representative without issues.System functioned as designed.System was not returned to manufacturer for analysis, therefore, no findings are possible.No further issues were reported.
Event or Problem Description
A medtronic representative reported that a patient had longer than usual swelling after a laser-induced thermal therapy procedure which was preformed on (b)(6) 2016.The swelling lasted for a month but the surgeon said he was used to around two weeks.There had been no issues during the case which took place on (b)(6) 2016.Medtronic was made aware of this on (b)(6) 2017.There was no reported delay to the procedure due to this issue.
Additional Manufacturer Narrative
Additional information: device manufacture date provided.Correction: device unique device identification (udi), part number, procode, common device name and 510(k) updated to proper values.A medtronic representative went to the site to test the equipment.The representative was unable to replicate the reported issue.The hardware, software, and instruments passed the system checkout.The system was found to be fully functional.The software investigation found that a probable cause was unable to be determined without further information since the on-going investigation proved to be inconclusive based on the information provided.

• Brand Name: SYSTEM 9735542 15W VISUALASE
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• MDR Report Key: 6450591
• Report Number: 1723170-2017-01442
• Device Sequence Number: 10981581
• Product Code: GEX
• UDI-Device Identifier: 00643169584440
• UDI-Public: 00643169584440
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K081656
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Catalogue Number: 9735542
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/02/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/31/2017
• Supplement Report FDA Received Date: 05/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other