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

Model Number ROSA ONE 3.1

Device Problem Patient Data Problem (3197)

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

Event Date 06/14/2021

Event Type  malfunction  

Manufacturer Narrative

Udi# : (b)(4).The device has not been evaluated yet for investigation purpose.Once the evaluation is performed, a follow-up medwatch report will be submitted.

Event Description

It was reported that it is impossible to import a patient folder in the robot and that some dicom are impossible to uplaod on the robot and the dicom was taken with the same process all the time.

Event Description

It was reported that it is impossible to import a patient folder in the robot and that some dicom are impossible to uplaod on the robot and the dicom was taken with the same process all the time.

Manufacturer Narrative

A full analysis of the data logs has been performed this analysis concluded that : an import of patient folder failure occured due to the failure of a dicom slice copy.However, the related dicom folder was not provided for the investigation due to an impossibility to copy the encrypted file from usb.Therefore, the cause for the issue cannot be determined.Among two exams reported to be acquired the same way, one could not be loaded through the software.Analysis revealed that the exam contained all slices duplicated ¿ which provoked an error of collinearity verification.An error of acquisition or unintentional data duplication is suspected, although the imagery acquisition was reported to be the same between both exams.Our analysis confirmed that the device behaved as expected.

• 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: 12158110
• MDR Text Key: 261222897
• Report Number: 3009185973-2021-00168
• 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: 09/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2021
• Is this an Adverse Event Report?: No
• 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: 3.1.5.1664
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1