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

Model Number STABILIZATION SYSTEM

Device Problem Unstable (1667)

Patient Problem No Patient Involvement (2645)

Event Date 10/29/2018

Event Type  malfunction  

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.

Event Description

The field service engineer assisted a unilateral seeg case at the (b)(6) hospital on (b)(6) 2018.The surgeon noted that the robot did not seem fully immobilized prior to the start of surgery.This had been the case for several surgeries and the surgeon was frustrated that this issue still existed.A few days prior to surgery ((b)(6) 2018), the field service engineer adjusted the stabilization system and achieved secure immobilization following work instruction.The stabilization system seemed to go back to being unstable by the morning of surgery.The field service engineer also noticed that the long and short rods used for adjusting the feet of the system seemed to be different from what the work instruction showed.The nuts that are responsible for tightening the short and long rods were at opposite ends of the rods, which could possibly be causing the issue.The nut on both the long rods was unreachable and could not be adjusted unless the robot was fully taken apart.Other observations have brought up the possibility of the floors being uneven in the or rooms.The storage room the robot is kept in seems to have the same effect, where at first the robot seems stable, but then after a few utilizations, it goes back to being unstable.As the surgeon has done for previous surgeries, the surgeon placed two sticky pads underneath the robot, and this allowed the robot system to be stable for surgery.There was not any stabilization issues during surgery after the pads were placed underneath.

Manufacturer Narrative

The manufacturing issue reported in this complaint was escalated through an issue evaluation which will assess if a corrective action must be conducted and through an health hazard evaluation determination to assess if a field action must be conducted.

Event Description

The field service engineer assisted a unilateral seeg case at the (b)(6) hospital on (b)(6) 2018.The surgeon noted that the robot did not seem fully immobilized prior to the start of surgery.This had been the case for several surgeries and the surgeon was frustrated that this issue still existed.A few days prior to surgery (2018-10-25), the field service engineer adjusted the stabilization system and achieved secure immobilization following work instruction.The stabilization system seemed to go back to being unstable by the morning of surgery.The field service engineer also noticed that the long and short rods used for adjusting the feet of the system seemed to be different from what the work instruction showed.The nuts that are responsible for tightening the short and long rods were at opposite ends of the rods, which could possibly be causing the issue.The nut on both the long rods was unreachable and could not be adjusted unless the robot was fully taken apart.Other observations have brought up the possibility of the floors being uneven in the or rooms.The storage room the robot is kept in seems to have the same effect, where at first the robot seems stable, but then after a few utilizations, it goes back to being unstable.As the surgeon has done for previous surgeries, the surgeon placed two sticky pads underneath the robot, and this allowed the robot system to be stable for surgery.There was not any stabilization issues during surgery after the pads were placed underneath.

Manufacturer Narrative

It was reported that the immobilization system of the device was unstable.Dhr review and review of complaint history did not identify any contributory factors to the event.The immobilization system was repaired by a field service technician.According to technical investigation this event was caused by the lack of information in the incoming control instruction : check of immobilization system feet assembly is missing.A request to escalate this issue in a non conformity was performed.

Event Description

The field service engineer assisted a unilateral seeg case at the university of michigan hospital on (b)(6) 2018.The surgeon noted that the robot did not seem fully immobilized prior to the start of surgery.This had been the case for several surgeries and the surgeon was frustrated that this issue still existed.A few days prior to surgery (2018), the field service engineer adjusted the stabilization system and achieved secure immobilization following work instruction.The stabilization system seemed to go back to being unstable by the morning of surgery.The field service engineer also noticed that the long and short rods used for adjusting the feet of the system seemed to be different from what the work instruction showed.The nuts that are responsible for tightening the short and long rods were at opposite ends of the rods, which could possibly be causing the issue.The nut on both the long rods was unreachable and could not be adjusted unless the robot was fully taken apart.Other observations have brought up the possibility of the floors being uneven in the or rooms.The storage room the robot is kept in seems to have the same effect, where at first the robot seems stable, but then after a few utilizations, it goes back to being unstable.As the surgeon has done for previous surgeries, the surgeon placed two sticky pads underneath the robot, and this allowed the robot system to be stable for surgery.There was not any stabilization issues during surgery after the pads were placed underneath.

• 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
• MDR Report Key: 8072919
• MDR Text Key: 128325895
• Report Number: 3009185973-2018-00308
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• PMA/PMN Number: K172444
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: STABILIZATION SYSTEM
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1