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

Catalog Number 9735542

Device Problems Imprecision (1307); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/07/2017

Event Type  malfunction  

Manufacturer Narrative

No parts were replaced and no parts have been received by the manufacturer for evaluation.Resolution confirmed on call.

Event Description

A medtronic representative reported that, while in a laser induced thermal therapy (litt) procedure to ablate the posterior parietal oligodendroglioma, the work station damage estimate was different from the post operative scan.The ablation damage estimate had been less than what was actually ablated, however the end result was what the surgeon wanted to ablate.During the procedure they had expected the damage estimate to be growing and it was not growing at one point.The inaccuracy of the damage area estimate was nearly 6mm from what was shown.There was no reported delay to the procedure due to this issue.There was no impact on patient outcome.

Manufacturer Narrative

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.

Manufacturer Narrative

The logs for the ablation system were reviewed by medtronic personnel.However, the logs provided no additional insight into the probable cause of the anomaly.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.

Manufacturer Narrative

The logs for the ablation system were reviewed by medtronic personnel.It was noted that phase drift was observed from the scanner during the session.

• 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: peter verhey ; navigation customer quality; 826 coal creek circle; louisville, CO 80027-9710
• MDR Report Key: 6768169
• MDR Text Key: 81850375
• Report Number: 1723170-2017-03213
• Device Sequence Number: 1
• Product Code: GEX
• UDI-Device Identifier: 00643169655935
• UDI-Public: 00643169655935
• 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: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 9735542
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/18/2016
• 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: 35 YR
• Patient Weight: 86