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

Catalog Number 9735542

Device Problems Imprecision (1307); Communication or Transmission Problem (2896)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/06/2016

Event Type  malfunction  

Manufacturer Narrative

Issue resolved at time of the reported event - confirmed no inaccuracy occurred post-op, following ablation.No parts were replaced.No further issues have been reported.

Event Description

A medtronic representative reported that, while in a corpus calistomoy laser induced thermal therapy (litt), there was an allegation that an inaccuracy may have occurred.No specific measurement, or direction, of the alleged inaccuracy was provided.Noted was that they were getting big signal voids in the software within the damage mode.Typically void is smaller and goes in and out, however, they were receiving very big voids.After ablation, it was confirmed there was no inaccuracy.The surgeon completed the procedure with the use of the navigation system and the thermal therapy system.There was no delay of therapy.There was no impact on patient outcome.

• 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: judith ericson ; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902187
• MDR Report Key: 5848043
• MDR Text Key: 51229621
• Report Number: 1723170-2016-02030
• Device Sequence Number: 1
• Product Code: GEX
• 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
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 08/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2016
• 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: 07/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/15/2016
• 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: 16 YR
• Patient Weight: 59