MAUDE Adverse Event Report: MEDTECH SAS ROSA ONE; COMPUTER-ASSISTED SURGICAL DEVICE

Model Number ROSA ONE 3.1

Device Problem Malposition of Device (2616)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/04/2021

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.Unique identifier (udi) #: (b)(4).

Event Description

It was reported that during a case at ochsner medical center, an issued occurred with the fixation of the arm in axial position.While performing a visualase case, we were positioned on trajectory 1 in axial position.The surgeon drilled, and then inserted the pmt visualase bolt into said trajectory.We then exchanged adapters to the rosa 3.2 metal drill bit to take the measurement for the laser fiber.Once this was done, the surgeon recognized that the trajectory was slightly below the implanted bolt.Following this, the surgeon was able to physically push the robot arm upwards (specifically, out of axial position) at minimum 4/5mm.This was while the robot arm was locked in axial position along the target.The surgeon immediately recognized that the arm was not locked in axial.A confirmation spin was completed, and the trajectory was only 2mm off target so the case was completed.

Event Description

It was reported that during a case at ochsner medical center, an issued occurred with the fixation of the arm in axial position.While performing a visualase case, the surgeon was positioned on trajectory 1 in axial position.The surgeon drilled, and then inserted the pmt visualase bolt into said trajectory.He then exchanged adapters to the rosa 3.2 metal drill bit to take the measurement for the laser fiber.Once this was done, the surgeon recognized that the trajectory was slightly below the implanted bolt.Following this, the surgeon was able to physically push the robot arm upwards (specifically, out of axial position) at minimum 4/5mm.This was while the robot arm was locked in axial position along the target.The surgeon immediately recognized that the arm was not locked in axial.A confirmation spin was completed, and the trajectory was only 2mm off target so the case was completed.

Manufacturer Narrative

A full analysis of the data logs has been performed and this analysis concluded that the review of data did not permit to confirm the event or a reliable root cause for the issue.However, the fse team information permitted to determined that an intervention of staübli was ordered to tightened the device breaks which permitted to reduce the error observed - only visible if a force is applied on the arm.It is noted forces applied on the arm during operation is not recommended according to the ifu.The analysis also shows that the marker registration verification was incorrectly performed which did not permit to confirm the registration accuracy.The dhr review permitted to confirm that the device passed two cycles of preventive maintenance showing that the device is compliant to its specifications.The event described in the complaint is confirmed by fse team information.

• Brand Name: ROSA ONE
• Type of Device: COMPUTER-ASSISTED SURGICAL DEVICE
• Manufacturer (Section D): MEDTECH SAS; 432 rue du rajol; 900 rue du mas de verchant; mauguio, languedoc-roussillon 34130 ; FR 34130
• Manufacturer (Section G): MEDTECH SAS; 432 rue du rajol; 900 rue du mas de verchant; mauguio, languedoc-roussillon 34130 ; FR 34130
• Manufacturer Contact: jay sharma ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 12745650
• MDR Text Key: 279882970
• Report Number: 3009185973-2021-00180
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200511
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ROSA ONE 3.1
• Device Catalogue Number: ROSAS00203
• Device Lot Number: 3.1.5.28
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/16/2018
• 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 Sequence Number: 1