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

Catalog Number 9735542

Device Problems Imprecision (1307); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Iatrogenic Source (2498)

Event Date 08/04/2017

Event Type  Injury  

Manufacturer Narrative

A medtronic representative reported that the issue has not repeated since the original occurrence and that the ablation system has been used since.

Event Description

A medtronic representative reported that, while in a amygdala-hippocampectomy procedure, the laser fiber being used was placed inaccurately.The reported imprecision was reported to have been 2 mm.The surgeon felt that the catheter was hitting bone at the skull, resulting in the trajectory of the catheter to shift.The representative reported that the ablation performed was not fully completed and that a second ablation has not been performed.It was noted that the angle of the trajectory led to the alignment catheter making contact with the bone.The surgeon elected to continue along that trajectory.There was a reported delay to the procedure of less than 1 hour due to this issue.No additional information was provided.

Manufacturer Narrative

Additional information: concomitant product added.

Manufacturer Narrative

The reported issue was evaluated by medtronic personnel.It was reported that the site uses a non-medtronic navigation system for procedures that do not involve a shunt placement.In this instance, the ablation system cannot navigate and would not have contributed to the reported issue.

• 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 ; attn:product quality experienc; 826 coal creek circle; louisville, CO 80027-9710
• MDR Report Key: 6838096
• MDR Text Key: 84350160
• Report Number: 1723170-2017-03586
• 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,user f
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup,Followup
• Report Date: 01/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: 9735542
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2016
• 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 Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Weight: 58