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

Catalog Number 9735542

Device Problems Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/02/2017

Event Type  malfunction  

Manufacturer Narrative

No parts have been received by the manufacturer for evaluation.Part not returned for evaluation.

Event Description

A medtronic representative reported that during soft tissue ablation (neuro) procedure, while receiving images from mri system, the software of the ablation system became unresponsive on the top of the screen.Exiting and entering the software resolved the issue.The procedure was completed with the use of medtronic ablation system.There was a delay of less than 1 hour.No impact on patient outcome.

Manufacturer Narrative

The logs for the ablation system were reviewed by medtronic personnel.The software investigation found that the reported event was unrelated to a software issue.The software functioned as designed.

• 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 ; attn:product quality experienc; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902515
• MDR Report Key: 7072024
• MDR Text Key: 93483447
• Report Number: 1723170-2017-04893
• 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,user f
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 01/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2017
• 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: 01/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2015
• 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: 22 YR
• Patient Weight: 47