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

Model Number ROSA ONE 3.1

Device Problem Intermittent Communication Failure (4038)

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

Event Date 04/26/2021

Event Type  Injury  

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.D4 unique identifier (udi) #: (b)(4).

Event Description

It was reported that during an seeg case, the rosa disconnected from the controller.This occurred after registration was complete and the rosa was at the home position.There was no obvious cause to the error.There was no patient impact.There was an hour delay to the case while the patient was under anesthesia.The controller would not reconnect after multiple shutdowns, with upwards of 3 minutes of power down before restart.The solution was deleting the "sfty.Dat" and "pdrv.Dat" files in ftp surfer for the controller.

Event Description

It was reported that during an seeg case, the rosa disconnected from the controller.This occurred after registration was complete and the rosa was at the home position.There was no obvious cause to the error.There was no patient impact.There was an hour delay to the case while the patient was under anesthesia.The controller would not reconnect after multiple shutdowns, with upwards of 3 minutes of power down before restart.The solution was deleting the 'sfty.Dat' and 'pdrv.Dat' files in ftp surfer for the controller.

Manufacturer Narrative

A full analysis of the data logs has been performed and this analysis concluded that the controller shut down following the activation of the emergency stop button.Two files were created in the controller folder because of a contact issue with the emergency stop button.Deleting these files permitted to connect the controller again.This issue will be addressed through the continuous improvement of our product.

• 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: 11789084
• MDR Text Key: 249428739
• Report Number: 3009185973-2021-00123
• 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,Followup
• Report Date: 05/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2021
• 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: 3.1.4.1650
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other