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

Catalog Number 9735542

Device Problems Display or Visual Feedback Problem (1184); Imprecision (1307)

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

Event Date 05/25/2018

Event Type  malfunction  

Manufacturer Narrative

A software investigation analysis was initiated to determine the probable cause of the issue through archive/image analysis.Analysis found that the images would align where the position information would match based on the prescription captured in the digital intercommunication of medicine (dicom) header.It was noted that the misalignment only occurred on images where the position information mismatched.Analysis found that the software functioned as designed.

Event Description

Medtronic received information that, while in a laser induced thermal therapy (litt), it was reported that the tmap and t1 background images would not align following the reformatting of the full-fiber image.It was noted that a second full catheter image was acquired after adjustment of the prescription and that images would not align.The site noted that the patient weight combined with a table shift were factors with the reported issue.There was no reported impact on patient outcome.No additional information was provided.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received additional information that this issue caused about a two hour delay.

• 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: 7625819
• MDR Text Key: 111903689
• Report Number: 1723170-2018-02920
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 05/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2018
• 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?: Yes
• Date Manufacturer Received: 05/10/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2016
• 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: 24 YR
• Patient Weight: 114