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

Model Number ROSA BRAIN

Device Problem Unintended Collision (1429)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/28/2019

Event Type  malfunction  

Manufacturer Narrative

Udi#: (b)(4).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

Surgeon requested instrument length be changed to 122 mm.Field service engineer informed surgeon that length less than 150 mm could be dangerous and that a collision hazard existed.Surgeon was aware and wanted to proceed.While navigating to trajectory, collision occurred and field service engineer stopped movement to position.Again surgeon was made aware that length was too close.Surgeon requested that measurement be changed again to 130 mm for all trajectories.Again navigated to the trajectory and distance was too close, a new collision occurred.Field service engineer again informed surgeon that distance was too close.Returned trajectory length to 200 mm.Surgery proceeded without intervention.No injury to patient, no additional intervention required.

Manufacturer Narrative

It was reported that multiple collisions occurred between tools and the patient or the robot arm during a surgery, due to the instrument length that was defined too short.Dhr review and review of complaint history did not identify any contributory factors to the event.According to technical investigation, planning a trajectory too close to the patient¿s head (reducing the length of the instrument) increases the collision hazard.The user must always monitor the robot arm position when it moves, as explained in the ifu and during the training.Furthermore, and as explained in the ifu, collision issues could have been avoided by releasing the foot pedal, and can be considered as a use error.

Event Description

Surgeon requested instrument length be changed to 122 mm.Field service engineer informed surgeon that length less than 150 mm could be dangerous and that a collision hazard existed.Surgeon was aware and wanted to proceed.While navigating to trajectory, collision occurred and field service engineer stopped movement to position.Again surgeon was made aware that length was too close.Surgeon requested that measurement be changed again to 130 mm for all trajectories.Again navigated to the trajectory and distance was too close, a new collision occurred.Field service engineer again informed surgeon that distance was too close.Returned trajectory length to 200 mm.Surgery proceeded without intervention.No injury to patient, no additional intervention required.

• 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: 8459390
• MDR Text Key: 140140835
• Report Number: 3009185973-2019-00106
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 06/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 06/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1