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

Catalog Number 002-1100

Device Problems Imprecision (1307); Improper Device Output (2953)

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

Event Date 10/06/2016

Event Type  malfunction  

Manufacturer Narrative

No patient weights are provided by the author(s).Ivan, michael e., roberto jose diaz, michael h.Berger, gregory w.Basil, david a.Osiason, thomas plate, amanda wallo, and ricardo j.Komotar."magnetic resonance¿guided laser ablation for the treatment of recurrent dural-based lesions: a series of five cases." world neurosurgery 98 (2016): 162-70.Web.No allegation of actual malfunction or inaccuracy of tissue ablation occurring.Article states that no adverse events related to the visualase system or the procedure occurred.No requests for system service have been received from the site regarding this issue.

Event Description

Per attached journal article entitled, magnetic resonanceeguided laser ablation for the treatment of recurrent dural-based lesions: a series of five cases by ivan et al, it is stated: "it remains to be determined whether the cell death estimates generated by the visualase system, which was designed for parenchymal brain lesions, reflects accurately the cell death induced in meningioma tissue by a given temperature and time.The damage estimate generated by the current software may not be an accurate reflection of cellular damage.Changes in mri signal and contrast enhancement after thermal ablation suggest alterations in water content, necrosis, and vessel coagulation; however, these changes must be further validated with detailed histologic examination." it is also stated that, " no patient experienced transient worsening of symptoms in the perioperative period or permanent side effects from the ablative procedure.All 5 patients were discharged home after the procedure on postoperative day one.".

• 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: catherine eaton ; 826 coal creek circle; louisville, CO 80027 ; 7208902092
• MDR Report Key: 6432969
• MDR Text Key: 70864244
• Report Number: 1723170-2017-01344
• 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: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 03/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 002-1100
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/23/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/19/2016
• 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: 65 YR