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 05/23/2019

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.  udi#: (b)(4).

Event Description

Seeg procedure with rosa completed successfully with 16 trajectories, bilateral.Upon post-operative ct imaging, it was noted that there was a significant bleed.The surgeon determined that the bleed was likely venous, and did not appear to cause mass displacement.During one of the trajectories, the surgeon did not pass an obturator or cannula prior to passing the electrode.The surgeon believed that the electrode may have skived due to the bleed.The surgeon declined a post-operative image fusion to the original rosa plan.He stated that the electrodes were placed accurately but the issue regarding the bleed was related to the obturator.

Event Description

Seeg procedure with rosa completed successfully with 16 trajectories, bilateral.Upon post-operative ct imaging, it was noted that there was a significant bleed.The surgeon determined that the bleed was likely venous, and did not appear to cause mass displacement.During one of the trajectories, the surgeon did not pass an obturator or cannula prior to passing the electrode.The surgeon believed that the electrode may have skived due to the bleed.The surgeon declined a post-operative image fusion to the original rosa plan.He stated that the electrodes were placed accurately but the issue regarding the bleed was related to the obturator.

Manufacturer Narrative

Dhr review and review of complaint history did not identify any contributory factors to the event.A detailed analysis of software logs concluded that the registration of the patient was properly executed.Elements provided for investigation did not permit to perform a complete analysis of the patient folder.Based on the investigation performed, no technical root cause can be confirmed since event is non-verifiable.The surgeon stated that the bleeding was due to lack of obturator use during first trajectories implantation.Corrected data: b4 date of this report, g4 date received by manufacturer, h2 if follow-up, what type, h3 device evaluated by manufacturer, and h6 event problem and evaluation codes.

• 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: 8716117
• MDR Text Key: 148540903
• Report Number: 3009185973-2019-00219
• 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
• Type of Report: Initial,Followup
• Report Date: 05/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2019
• 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: 05/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other