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

Model Number PLANNING STATION

Device Problem Data Problem (3196)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/25/2020

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

Unable to load exported plans from the laptop after the software upgrade.This issue only applies to the patient folders created after the upgrade, all of the old patient folders are able to load.Company representative was able to make the folder load by modifying crc code, however after trying again (to test) the patient folder didn¿t load.

Manufacturer Narrative

A full analysis of the data logs has been performed.This analysis concluded that the patient folders were unable to be loaded onto the robot because of the patient folders settings, that were in 'hide' mode.After changing this, the issue did not occur anymore.Based on the investigation performed, the technical root cause of the event was determined to be incorrect parameters.D4 unique identifier (udi) #:(b)(4).Corrected data: b4 date of this report 4 model number / catalog number / serial number / lot number.G3 date received by manufacturer.H2 if follow-up, what type.H3 device evaluated by manufacturer.H4 device manufacturer date.H6 adverse event problem.H10 additional narratives/data.

Event Description

Unable to load exported plans from the laptop after the software upgrade.This issue only applies to the patient folders created after the upgrade, all of the old patient folders are able to load.Company representative was able to make the folder load by modifying crc code, however after trying again (to test) the patient folder didn¿t load.

• 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: 10635420
• MDR Text Key: 210003110
• Report Number: 3009185973-2020-00234
• 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: 04/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PLANNING STATION
• Device Catalogue Number: ROSAS00503
• Device Lot Number: 3.1.4.1650
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/25/2020
• Initial Date FDA Received: 10/06/2020
• Supplement Dates Manufacturer Received: 04/21/2021
• Supplement Dates FDA Received: 04/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1