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

Model Number ROSA ONE 3.1

Device Problem Application Program Problem (2880)

Patient Problem No Patient Involvement (2645)

Event Date 02/12/2021

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

The clinical representative (cr) was in (b)(6) for the spine applicative training.When start the rosa robot, the system brought up an robotic error.System had to be shut down.The cr powered the system of for about 60 secs.The next start was successful.The cr went through the setup procedure and the ziehm imaging system told he is ready for the scan.The cr started the countdown for image acquisition.The ziehm brought up a collision warning.The ziehm and table had to be repositioned.The cr tried to abort image transfer, but system froze and had to be restarted.After restart, system when through robot camera registration again, which had been done successful before.Next attempt transfer worked.

Manufacturer Narrative

A full analysis of the data logs has been performed and this analysis concluded that : the arm failed to connect twice due to a communication failure between the robotic software and the robot arm controller.This issue will be addressed through the continuous improvement process of our products.Two software unexpected interruption were detected and required software restart.One was due to a system freeze and the other due to the application software freeze.The cause for those errors cannot be determined.

Event Description

The clinical representative (cr) was in university frankfurt for the spine applicative training.When start the rosa robot, the system brought up an robotic error.System had to be shut down.The cr powered the system of for about 60 secs.The next start was successful.The cr went through the setup procedure and the ziehm imaging system told he is ready for the scan.The cr started the countdown for image aquisition.The ziehm brought up a collision warning.The ziehm and table had to be repositioned.The cr tried to abort image transfer, but system froze and had to be restarted.After restart, system when through robot camera registration again, which had been done successful before.Next attempt tranfer worked.

• 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: 11371837
• MDR Text Key: 233320633
• Report Number: 3009185973-2021-00063
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K192173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2021
• 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: ROSAS00209
• Device Lot Number: 3.1.4.1650
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/23/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2019
• 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