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

Model Number ROSAS00203

Device Problem Image Display Error/Artifact (1304)

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

Event Date 02/17/2021

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

Company representative was present for a brain surgery.During the case, the surgeon took a pre-operative airo scan to use as his registration scan.When loading the scan in, the surgeon had to adjust and recalculate the merge several times before he was happy with the merge accuracy.After implantation, the surgeon got another scan to confirm lead placement and trajectory accuracy.Again, the surgeon had to adjust and recalculate the merge several times before he was happy with the merge accuracy.Delay to case about 10 mins, no patient impact.Patient was already under anesthesia and after first incision.

Manufacturer Narrative

A full analysis of the data logs has been performed and permitted to conclude that the event reported is a known software anomaly.This analysis concluded that the recalculate function was used following manual adjustments, as expected, but was unsuccessful since manual adjustments were needed again.This software anomaly will be addressed through our design issues management process.

Event Description

Company representative was present for a brain surgery.During the case, the surgeon took a pre-operative airo scan to use as his registration scan.When loading the scan in, the surgeon had to adjust and recalculate the merge several times before he was happy with the merge accuracy.After implantation, the surgeon got another scan to confirm lead placement and trajectory accuracy.Again, the surgeon had to adjust and recalculate the merge several times before he was happy with the merge accuracy.Delay to case about 10 mins, no patient impact.Patient was already under anesthesia and after first incision.

• 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: 11517121
• MDR Text Key: 242167064
• Report Number: 3009185973-2021-00079
• 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: 03/19/2021

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: ROSAS00203
• Device Catalogue Number: ROSA ONE
• Device Lot Number: 3.1.4.1650
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/17/2021
• Initial Date FDA Received: 03/18/2021
• Supplement Dates Manufacturer Received: 03/19/2021
• Supplement Dates FDA Received: 03/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1