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

Model Number ROSA BRAIN 3.0

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Hemorrhage, Cerebral (1889)

Event Date 11/09/2018

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. (b)(4).

Event Description

While drilling the lain trajectory, the 2 surgeons noted a bit of blood along with csf drip from the anchor bolt.After drilling lpin trajectory, one of the surgeon also observed blood dripping with csf from the bolt and was concerned that a hemorrhage had occurred.The surgery was finished and the patient was taken to ct.The ct revealed a minor hemorrhage of the dural vasculature in lain.One of the surgeon opted for no surgical intervention and will continue to monitor the patient.This does not appear to be due to inaccuracy of the rosa and appears to be due to planning close to vessels in the dura.The surgeon explained that these vessels aren't as highly scrutinized as deep vessels when planning.The field service engineer spoke with the surgeon after the case, the bleed seemed to have been caused by drilling and not the obturator or electrode.

Event Description

While drilling the lain trajectory, the 2 surgeons noted a bit of blood along with csf drip from the anchor bolt.After drilling lpin trajectory, one of the surgeon also observed blood dripping with csf from the bolt and was concerned that a hemorrhage had occurred.The surgery was finished and the patient was taken to ct.The ct revealed a minor hemorrhage of the dural vasculature in lain.One of the surgeon opted for no surgical intervention and will continue to monitor the patient.This does not appear to be due to inaccuracy of the rosa and appears to be due to planning close to vessels in the dura.The surgeon explained that these vessels aren't as highly scrutinized as deep vessels when planning.The field service engineer spoke with the surgeon after the case, the bleed seemed to have been caused by drilling and not the obturator or electrode.

Manufacturer Narrative

It was reported that a dural hemorrhage was noticed during the surgery.A dhr review and a complaint history review were performed and did not identify any contributory factors to the event.A full analysis of data log indicates that the device worked as expected and that all trajectories were implanted with accuracy.The user explained that the hemorrhage was likely due to a planning close to vessels in the dura and that the drilling triggered the bleeding.It is the most probable root cause.No adverse events or serious injuries were reported regarding to the care of the patient.Unique identifier (udi) number: (b)(4).

Manufacturer Narrative

This report is provided to correct the udi number provided in section h10 of the initial report.(b)(4).

Event Description

While drilling the lain trajectory, the 2 surgeons noted a bit of blood along with csf drip from the anchor bolt.After drilling lpin trajectory,one of the surgeon also observed blood dripping with csf from the bolt and was concerned that a hemorrhage had occurred.The surgery was finished and the patient was taken to ct.The ct revealed a minor hemorrhage of the dural vasculature in lain.One of the surgeon opted for no surgical intervention and will continue to monitor the patient.This does not appear to be due to inaccuracy of the rosa and appears to be due to planning close to vessels in the dura.The surgeon explained that these vessels aren't as highly scrutinized as deep vessels when planning.The field service engineer spoke with the surgeon after the case, the bleed seemed to have been caused by drilling and not the obturator or electrode.

• 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: 8136941
• MDR Text Key: 129505642
• Report Number: 3009185973-2018-00348
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• PMA/PMN Number: K172444
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Inspection
• Type of Report: Initial,Followup,Followup
• Report Date: 08/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ROSA BRAIN 3.0
• Device Catalogue Number: ROSA BRAIN
• Device Lot Number: 3.0.0.21
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other