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

Model Number ROSA ONE 3.1

Device Problem Computer Software Problem (1112)

Patient Problem No Code Available (3191)

Event Date 11/10/2020

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

The following event occurred after a dbs case on (b)(6) 2020 with the clinical representative (cr): the post-operative ct scan was taken and merged to the plan.The merge was accepted, and while looking at the post-operative scan, the left lead was 4 mm deep, while the right lead had no issues.The surgeon determined that the lead would need to be 'pulled back' 4 mm.A revision surgery was performed for retract the lead 4 mm, and another post operative scan was taken.When this scan was merged it was determined that the lead was in the right spot.

Event Description

The following event occurred after a dbs case on (b)(6) 2020 with the clinical representative (cr): the post-operative ct scan was taken and merged to the plan.The merge was accepted, and while looking at the post-operative scan, the left lead was 4 mm deep, while the right lead had no issues.The surgeon determined that the lead would need to be 'pulled back' 4 mm.A revision surgery was performed for retract the lead 4 mm, and another post operative scan was taken.When this scan was merged it was determined that the lead was in the right spot.

Manufacturer Narrative

A full analysis of the data logs has been performed ans this analysis concluded that the device behaved as expected.The left electrode had been implanted too deep, but after it was manually retracted by the surgeon, it was accurately positioned.The accuracy in depth depends on the method of implantation.In this case, the elements of analysis indicate that the device operated within specifications.

• 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: 10910420
• MDR Text Key: 218521148
• Report Number: 3009185973-2020-00313
• 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: 04/15/2021

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?: 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
• Initial Date Manufacturer Received: 11/11/2020
• Initial Date FDA Received: 11/26/2020
• Supplement Dates Manufacturer Received: 04/13/2021
• Supplement Dates FDA Received: 04/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other