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

Model Number ROSAS00082

Device Problem Defective Component (2292)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/10/2019

Event Type  malfunction  

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

On (b)(6), the surgeon was preforming a 13 trajectory seeg case.The patient was put under anesthesia, pinned, attached to the robot and registered using contactless registration.The field service engineer was the clinical rep on site, and set the robot to drive to trajectory 1.Once on trajectory, the arm was moved in axial slow along the trajectory and the resident started to drill.The drill made a strange noise, and then realized that the drill was not turning.This happened almost immediately after he started drilling.A new drill and drill guide were used for the remainder of the case and the case proceeded without any other trouble.At the end of the case, there were attempts to get the drill out of the guide, but it was not moving.

Manufacturer Narrative

It was reported that a drill bit go stuck in a drill bit adaptor during a surgery.Dhr review and review of complaint history were not performed based on the low severity of this complaint.According to technical investigation, damages were visible on the drill bit and the drill adaptor.However, the root cause of the event cannot be determined.The most probable root cause is that the drill bit was not inserted co-axially during drilling.

Event Description

On (b)(6), the surgeon was preforming a 13 trajectory seeg case.The patient was put under anesthesia, pinned, attached to the robot and registered using contactless registration.The field service engineer was the clinical rep on site, and set the robot to drive to trajectory 1.Once on trajectory, the arm was moved in axial slow along the trajectory and the resident started to drill.The drill made a strange noise, and then realized that the drill was not turning.This happened almost immediately after he started drilling.A new drill and drill guide were used for the remainder of the case and the case proceeded without any other trouble.At the end of the case, there were attempts to get the drill out of the guide, but it was not moving.

Manufacturer Narrative

The drill adaptor mt-02-161 s18251 has been received at manufacturing site on (b)(6) 2019.

Event Description

On 10-july, the surgeon was preforming a 13 trajectory seeg case.The patient was put under anesthesia, pinned, attached to the robot and registered using contactless registration.The field service engineer was the clinical rep on site, and set the robot to drive to trajectory 1.Once on trajectory, the arm was moved in axial slow along the trajectory and the resident started to drill.The drill made a strange noise, and then realized that the drill was not turning.This happened almost immediately after he started drilling.A new drill and drill guide were used for the remainder of the case and the case proceeded without any other trouble.At the end of the case, there were attempts to get the drill out of the guide, but it was not moving.

• 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: 8854114
• MDR Text Key: 201404793
• Report Number: 3009185973-2019-00248
• 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,Followup
• Report Date: 12/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ROSAS00082
• Device Catalogue Number: DRILL ADAPTOR
• Device Lot Number: ROSA3-283A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1