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

Model Number ROSA BRAIN

Device Problem Insufficient Information (3190)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 10/02/2018

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.

Event Description

A field service engineer was notified that rosa seeg surgery was postponed after 5 electrodes were already implanted due to a cortical bleed.The field service engineer was not present for this case.Surgeon indicated that the patient is doing well enough to proceed with second round of electrode implantation on (b)(6) 2018.

Manufacturer Narrative

It was reported that a patient experienced a cortical bleeding during a seeg surgery.Dhr review and review of complaint history did not identify any contributory factors to the event.Workflow of the surgery was reviewed and recreated at manufacturing site.According to technical investigation the device worked as expected, there was no malfunction.The most probable root causes of this event would be either an incorrect fusion or an inelastic movement of the head in the frontal direction.The surgeons agreed that the bone bleed occurred because the obturator was passing through a vessel, and did not result from an issue with the rosa brain device.

Event Description

A field service engineer was notified that rosa seeg surgery was postponed after 5 electrodes were already implanted due to a cortical bleed.The field service engineer was not present for this case.Surgeon indicated that the patient is doing well enough to proceed with second round of electrode implantation on (b)(6) 2018.

• Brand Name: ROSA BRAIN
• 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: 7994670
• MDR Text Key: 124677200
• Report Number: 3009185973-2018-00283
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• PMA/PMN Number: K151359
• 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: 04/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ROSA BRAIN
• Device Catalogue Number: N/A
• Device Lot Number: 3.0.0.21
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other