MAUDE Adverse Event Report: MEDTECH SA ROSA BRAIN COMPUTER-ASSISTED SURGICAL DEVICE

Model Number ROSA BRAIN

Device Problem Imprecision (1307)

Patient Problems Laceration(s) (1946); No Code Available (3191)

Event Date 02/07/2019

Event Type  Injury  

Manufacturer Narrative

The device has not been evaluated yet for investigation purpose. Once the evaluation is performed, a follow-up medwatch report will be submitted. (b)(4).

Event Description

Patient was brought in room and head was fixated onto the bed as well as being attached to the rosa brain. Once the robot was attached, it was noticed that the monteris head fixation was going to be impeding with the trajectory; therefore, the surgeon and the operating room staff decided to utilize the doro threepin head fixation device. The single pin was placed on the left forehead near the hairline and the two-pin side was positioned on the back right of the head. The patients was supine with about a 60 degree head tilt to the left. The patient then was connected directly to rosa brain. The laser registration was performed. After completing registration, it was that the rosa brain stabilization system waw not locked down. The surgeon was informed and instead of re-doing registration, he decided to perform the verification once more with the stabilization system locked. Re-verification successfully passed. A ct scan was performed and was merged to rosa. Patient was draped and the procedure was ready to begin. The patient previously had a craniotomy in this area and had a mesh plate implanted. Therefore, the surgeon could not place a bolt in this area due to there being no bone. The surgeon instead cut an area of the mesh plate away and used a axiis device, which is a 3 legged stabilization device with lag screws to fixate to the skull for accurate placement of the ablation probe. The surgeon attempted to place the axiis device but wasn¿t getting good purchase of the lag screws in the bone. The surgeon attempted to place the axis with rosa brain guidance and a mandrel was placed in the axiis guidance tube to about where the outer table of the bone would be. A ct scan was aken at this time and the trajectory was superior and anterior of the target by about 4mm. The surgeon assumed the inaccuracy was due to the axiis not being fixated securely. The surgeon attempted to better secure the axiis again and reposition it with the rosa brain. After another ct, the target was once again superior and anterior. The surgeon went back once again and tried using another axiis device, in which we was able to get it securely fixated to the skull. The surgeon then attempted to reposition the axiis to be aligned with the rosa brain 3 additional times in which resulted in the trajectory still being off alignment. On the last attempt, the surgeon tried to isocentrically move the robot arm about the entry point to compensate for the error that was occurring. The final ct was performed and the surgeon had placed the mandral into the brain and deployed it about 30mm past the target. The ct showed this result and the trajectory was still off from the target. At this time, the surgeon decided to abort the case. When undraping the patient, it was found that the patient had lacerations to the head due to the pins of the doro head fixation device not being securely fixated to the head. The surgeon agreed that this was the reason for the inaccuracies during the case.

• Brand Name: ROSA BRAIN
• Type of Device: COMPUTER-ASSISTED SURGICAL DEVICE
• Manufacturer (Section D): MEDTECH SA; zac eureka; 900 rue du mas de verchant; montpellier, languedoc-roussillon 34000 ; FR 34000
• Manufacturer (Section G): MEDTECH SA; zac eureka; 900 rue du mas de verchant; montpellier, languedoc-roussillon 34000 ; FR 34000
• Manufacturer Contact: jay sharma ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 8394316
• MDR Text Key: 137946510
• Report Number: 3009185973-2019-00067
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172444
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: ROSA BRAIN
• Device Catalogue Number: N/A
• Device Lot Number: 3.0.0.21
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 01/24/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/23/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A

Patient Treatment Data

Date Received: 03/06/2019 Patient Sequence Number: 1