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

Model Number ROSA ONE 3.1

Device Problems Computer Software Problem (1112); Unintended Collision (1429)

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

Event Date 04/27/2022

Event Type  malfunction  

Event Description

Robot arm collided against robotic base when orienting itself for trajectory 5.Robot did not prompt the trajectory was inaccessible with the microdrive holder.All trajectories were edited after contactless registration.After restarting the system, clinical representative (cr) was able to clear the robotic arm.However, after the shutdown, during the vigilance device error message, 'clear robot arm' choice prompted an empty calibration.Cr recognized this as the software¿s field action events.To clear the robot, cr drove the robot home.

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).

Manufacturer Narrative

Dhr review and review of complaint history did not identify any contributory factors to the event.A full analysis of the data logs has been performed and concluded that the first device restart was due to a collision of the arm which provoked the detection of an over force.The collision could have been avoided by releasing the vigilance device.After restart, the arm empty calibration was requested when the arm was still navigated with a tool installed.This is a known software anomaly that was escalated as a field action zfa-2021-00198, fda reference z-0118-2022.

Event Description

Robot arm collided against robotic base when orienting itself for trajectory 5.Robot did not prompt the trajectory was inaccessible with the microdrive holder.All trajectories were edited after contactless registration.After restarting the system, clinical representative (cr) was able to clear the robotic arm.However, after the shutdown, during the vigilance device error message, 'clear robot arm' choice prompted an empty calibration.Cr recognized this as the software¿s field action events.To clear the robot, cr drove the robot home.

• Brand Name: ROSA ONE
• Type of Device: COMPUTER-ASSISTED SURGICAL DEVICE
• Manufacturer (Section D): MEDTECH SAS; 432 rue du rajol; mauguio, languedoc-roussillon 34130 ; FR 34130
• Manufacturer (Section G): MEDTECH SAS; 432 rue du rajol; mauguio, languedoc-roussillon 34130 ; FR 34130
• Manufacturer Contact: jay sharma ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 14367332
• MDR Text Key: 293143101
• Report Number: 3009185973-2022-00029
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 06/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• 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: 06/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/11/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: Z-0118-2022
• Patient Sequence Number: 1