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

Catalog Number 9735542

Device Problems No Display/Image (1183); Patient-Device Incompatibility (2682); Application Program Problem (2880); Device Operates Differently Than Expected (2913); Device Sensing Problem (2917)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/13/2016

Event Type  malfunction  

Manufacturer Narrative

The medtronic representative confirmed that the same visualase thermal therapy system and scanner were used in another procedure performed hours before, in the same room, with no issues.On 10/25/2016 medtronic representative reported that the background is regarding a large body habitus patient that had an occipital approach.The primary scanner coil would not afford the patient to fit without damaging the fiber.We switched to that rooms only other option, which was a 4-channel transmit only body coil.Although the tmap represented changes in artifact temperature variations, it refused to display temperature variations surrounding the fiber.After trouble-shooting steps and process of elimination, we transferred the patient to their secondary scanner, which has a better head coil that is clamshell and separates into two halves.On 11/08/2016 a medtronic representative, following-up at the site, reported the image was normal in appearance and some thermography noise could be seen, just no change in temperature.It was definitely a very old body coil that was used.On 10/31/2016 a medtronic representative performed a thermal therapy system check-out, all areas passed.System performed as intended.

Event Description

A medtronic representative reported that, while in a laser induced thermal therapy (litt) procedure, they were unable to see any temperature change on the t-map.This occurred while only at a test dose wattage.There was no heat ablation shown on the monitor screen.In trouble-shooting, confirmed the indication light showed that the disposable was connected.They were using a body coil, transceiver only.Confirmed good connection to the mri machine (ge scanner).The medtronic representative re-started the session and re-started software without resolution.The surgeon opted to continue and completed the procedure with the use of the thermal therapy system.Delay in therapy was greater than one hour before continuing.There was no impact on patient outcome.

Manufacturer Narrative

Correction: correcting patient information to appropriate values.

• 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 ; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902187
• MDR Report Key: 6095068
• MDR Text Key: 59840379
• Report Number: 1723170-2016-02885
• 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
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 03/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 10/13/2016
• Initial Date FDA Received: 11/11/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/06/2015
• 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: 69 YR
• Patient Weight: 82