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

Model Number ROSA ONE 3.1

Device Problem Unintended Collision (1429)

Patient Problem No Code Available (3191)

Event Date 07/24/2020

Event Type  Injury  

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.This analysis concluded that a collision occurred between the cannula holder and the patient reference.The patient was not injured or affected due to the collision.A review of the ifu has also been performed and the user manual indicates how to avoid robot arm collisions.Therefore, based on the investigation performed, the technical root cause of the event was determined to be use error mismanagement of the vigilance device.(b)(4).

Event Description

After completion of registration and intraoperative image acquisition for the rosa spine robot, the surgeon planned his screw trajectories.Once planning was completed, the clinical representative (cr) drove to the first screw.The surgeon was looking away from the robot while on the pedal.The cr was trying to watch the arm movement as well so that it did not run into the patient reference, but the instrument holder ended up colliding with the patient reference.Due to the collision, the patient reference did loosen from the psis pin.Because of this the cr informed the surgeon that another intraoperative scan would have to be performed.The surgeon decided to abort the case using rosa and decided to place the pedicle screws in the traditional technique.The patient was not injured or effected due to the collision.

• 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
• 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: 10740108
• MDR Text Key: 213230374
• Report Number: 3009185973-2020-00286
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 3.1.3.1494
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/24/2020
• Initial Date FDA Received: 10/27/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/04/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other