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

Catalog Number 9735542

Device Problems Computer Software Problem (1112); Imprecision (1307)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/20/2018

Event Type  malfunction  

Manufacturer Narrative

Device manufacturing date is unavailable.A software investigation analysis was initiated to determine the probable cause of the issue through review of the reported issue.Analysis found that the visualase software was functioning as designed.No failure found.

Event Description

Medtronic received information regarding a navigation device being used for a soft tissue ablation procedure.It was reported that upon insertion of the ceramic stylet 2d radial error was calculated to be.7 mm, and verbally confirmed as an acceptable location by the surgeon.It was reported that the clearpoint frame was aligned, a hole was drilled and a scan may have been performed after drilling and the clearpoint frame was placed to target.Scan was taken with clearpoint ceramic stylet with a diameter of about 2 millimeters.Surgeon and representative verified tit and a ablation system catheter was placed.The catheter was inserted through the clearpoint frame using a titanium stylet and the stylet was swapped for the fiber.The normal ablation system scanning was performed.When a 3d volume was performed to find the fiber, 2 fiber planes were found that showed the full length of the fiber.There was only one track visible.Surgeon set up the t-maps and then the 2d t1 background images.Surgeon looked at the 3d scans.When surgeon looked at the 2d t1 images on the ablation system screen prior to ablation, surgeon suspected it looked a little lateral than planned.After performing ablation, surgeon decided to adjust the clearpoint frame for subsequent ablation to see if that helped.Catheter was removed and clearpoint frame was adjusted.The ablation system catheter was put back in with stiffening style.No scan was performed with the clearpoint stylet and the representative reported the site did not scan the frame with visualization tube to check the trajectory.An ablation system scan was processed again and it appeared that the catheter ended up in the same track as before.There was only one visible track.Surgeon decided to proceed and more ablations were performed.It was reported that the site was using clearpoint software and a clearpoint frame to place the laser.The procedure was completed with the use of ablation system.No known impact on patient outcome.No information was provided on delay to procedure.

Manufacturer Narrative

Additional information: manufacture date provided.

• Brand Name: SYSTEM 9735542 15W VISUALASE
• Type of Device: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: prashanth gali ; navigation customer quality; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902515
• MDR Report Key: 7691786
• MDR Text Key: 114152326
• Report Number: 1723170-2018-03467
• Device Sequence Number: 1
• Product Code: GEX
• UDI-Device Identifier: 00643169792890
• UDI-Public: 00643169792890
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081656
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 07/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 9735542
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/17/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/21/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Weight: 44