MAUDE Adverse Event Report: MEDTECH SA 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.

• Brand Name: ROSA ONE
• 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: 12745650
• MDR Text Key: 279882970
• Report Number: 3009185973-2021-00180
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• PMA/PMN Number: K200511
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial
• Report Date: 11/03/2021

1 Device was Involved in the Event

0 Patients were 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

• Device Model Number: ROSA ONE 3.1
• Device Catalogue Number: ROSAS00203
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 10/04/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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