MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) SYSTEM 002-1100 15W THERMAL THERAPY; POWERED LASER SURGICAL INSTRUMENT

Catalog Number 002-1100

Device Problem Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/02/2015

Event Type  malfunction  

Manufacturer Narrative

Patient information was not made available from the site.Software investigation has not been completed.

Event Description

A medtronic representative reported that, while in a live laser induced thermal therapy session,the laser turned off, a window displayed, flashed and the thermal therapy system became unresponsive.In trouble-shooting, the medtronic representative attempted to terminate dialog box and shut-down thermal therapy system without success.Hard shut-down was performed and thermal therapy system resumed normal functionality.There was no delay of therapy reported.The surgeon completed the procedure with the use of the thermal therapy system.There was no impact on patient outcome.

Manufacturer Narrative

Correction: the reported incident caused a 5 minute delay to the surgery.Additional information: the site does not have an active contract to upgrade the system.A medtronic representative reported that there are no plans at the site to upgrade the system hardware and software.The software investigation found that the reported event was related to a software issue that was fixed in a subsequent software version.A review of the log files and system info package provided confirmed that the software version used was out of date.The described event in complaint has previously been identified and fixed in the newer version.There are no patches or hotfixes available for the previous version.An upgrade was recommended, however the site has not chosen to upgrade the system.The issue is correctable during use via a reboot and there have been no further issues reported.

• Brand Name: SYSTEM 002-1100 15W THERMAL THERAPY
• 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: amos jarrette ; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902082
• MDR Report Key: 5250751
• MDR Text Key: 32161575
• Report Number: 1723170-2015-01469
• 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,Followup
• Report Date: 12/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Medical Equipment Company Technician/Representative
• Device Catalogue Number: 002-1100
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2013
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Weight: 109