MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) SYSTEM 002-1100 15W THERMAL THERAPY; POWERED LASER SURGICAL INSTRUMENT

Catalog Number	9735542
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information was unavailable from the site.Device manufacturing date was unavailable.A manufacturer representative reported that there were no issues in subsequent cases.No parts have been received by the manufacturer for evaluation.
Event or Problem Description
A manufacturer representative reported via a surgeon that they were not seeing the dmaps as expected during a laser induced thermal therapy (litt).While the thermal overlay was showing us temperature changes and spread, the damage estimate images did show change, but not as much as the surgeon expected.They restarted the session, however the same behavior continued.They stopped and took a post-op scan and were able to confirm that the actual ablation was more that what was being showed on the software.They were happy with the actual ablation shown.There was no delay or reported impact on patient outcome.
Additional Manufacturer Narrative
Additional information: udi, part number and device manufacturing date provided.Patient information was available from the site.
Additional Manufacturer Narrative
Data logs from the event date were provided to medtronic for review.However, review of the logs found insufficient information to determine the probable cause of the anomaly.

• Brand Name: SYSTEM 002-1100 15W THERMAL THERAPY
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• MDR Report Key: 7364309
• Report Number: 1723170-2018-01267
• Device Sequence Number: 19095813
• Product Code: GEX
• UDI-Device Identifier: 00643169584440
• UDI-Public: 00643169584440
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/04/2018

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: 9735542
• Initial Date Received by Manufacturer: 02/13/2018
• Supplement Date Received by Manufacturer: 03/26/2018; 05/08/2018
• Initial Report FDA Received Date: 03/22/2018
• Supplement Report FDA Received Date: 04/05/2018; 06/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 56