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

Catalog Number 9735542

Device Problem Imprecision (1307)

Patient Problem Intracranial Hemorrhage (1891)

Event Date 03/23/2018

Event Type  Injury  

Manufacturer Narrative

A medtronic representative went to the site to test the equipment.The imaging system then passed the system checkout and was found to be fully functional.No parts have been received by the manufacturer for evaluation.

Event Description

Information was received from a site regarding a navigation system issue that occurred during a soft tissue ablation procedure.It was reported that during the case, the trajectory was off and it resulted in a brain bleed.The site ended the procedure.No further information was available.

Manufacturer Narrative

Medtronic received information that there was no delay prior to discontinuing the case as they stopped immediately after the issue occurred.It was also confirmed that the alleged inaccuracy was not caused by a medtronic system as the medtronic system was not even turn on yet when reported incident occurred.The most likely cause of the inaccuracy was a third party product, called "rosa robot" manufactured by zimmer biomet (formerly medtech).If this information was available during the initial review, the reported event would not have been considered a medtronic reportable malfunction.

• 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: amos jarrette ; navigation customer quality; 826 coal creek circle; louisville, CO 80027-9710 ; 7208903200
• MDR Report Key: 7447250
• MDR Text Key: 106059761
• Report Number: 1723170-2018-01702
• 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: 05/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 9735542
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/24/2015
• 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 Outcome(s): Required Intervention
• Patient Age: 44 YR
• Patient Weight: 68