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

Model Number ROSA ONE

Device Problem Data Problem (3196)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/03/2021

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.Unique identifier (udi) #: (b)(4).

Event Description

Surgeon noted that trajectory placement seemed incorrect - concerned that export was incorrect.Surgeon re-opened laptop to confirm that trajectory placement was correctly planned on planning software.Surgeon noted that he believed that planning had not saved properly, but it might be possible that he forgot to save prior to export.Surgeon confirmed trajectories before proceeding, delay 15 minutes.

Event Description

Surgeon noted that trajectory placement seemed incorrect - concerned that export was incorrect.Surgeon re-opened laptop to confirm that trajectory placement was correctly planned on planning software.Surgeon noted that he believed that planning had not saved properly, but it might be possible that he forgot to save prior to export.Surgeon confirmed trajectories before proceeding, delay 15 minutes.

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 did not show any issue during export or import of the patient folder.This could be consistent with the suggestion made in the complaint description: the user could have forgotten to save before export, but this hypothesis could not be confirmed with the data.The root cause for the event could not be determined.

• 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: 11371748
• MDR Text Key: 233264453
• Report Number: 3009185973-2021-00060
• 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: 08/03/2021

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?: No
• Device Operator: Health Professional
• Device Model Number: ROSA ONE
• Device Catalogue Number: ROSAS00216
• Device Lot Number: 3.1.4.1650
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/03/2021
• Initial Date FDA Received: 02/24/2021
• Supplement Dates Manufacturer Received: 08/03/2021
• Supplement Dates FDA Received: 08/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other