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

Model Number ROSA ONE

Device Problems Malposition of Device (2616); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hematoma (1884); Hemorrhage, Subdural (1894)

Event Date 10/07/2020

Event Type  Injury  

Manufacturer Narrative

Initial report : 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 company clinical representative informed about a case inaccuracy.This case also had a subdural hematoma that very well could have been the result of this inaccuracy.The subdural hematoma required a craniotomy, and ending the subdural bleeding that was occurring.This process of the craniotomy added roughly an hour to the procedure.

Manufacturer Narrative

A full analysis of the logs and of the patient folder has been performed.This analysis concluded that all the electrodes had been implanted with an inaccuracy superior to 2 mm at their entry point.The root cause of these inaccuracies at the entry point remains unknown.No specific trend was observed for the deviations, and there is no indication of any head movement.Reportedly, the fusion of the postoperative scan confirmed that the electrodes were accurate at the target points.The location and the origin of the hemorrhage could not be determined.The surgeon communicated that he did not know which trajectory provoked the bleeding or how it was provoked.A preventive maintenance was carried out on the 25th of november 2020, and the device passed all the tests with success.Based on the investigation performed, the technical root cause of the event cannot be determined.

Event Description

The company clinical representative informed about a case inaccuracy.This case also had a subdural hematoma that very well could have been the result of this inaccuracy.The subdural hematoma required a craniotomy and ending the subdural bleeding that was occurring.This process of the craniotomy added roughly an hour to the procedure.

• 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: 10771178
• MDR Text Key: 214135895
• Report Number: 3009185973-2020-00288
• 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: 01/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ROSA ONE
• Device Catalogue Number: ROSAS00203
• Device Lot Number: 3.1.4.1650
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1