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 11/19/2018

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.

Event Description

After finishing contactless registration on patient, the robot arm collided with the mayfield head holder during automatic move back to the home position.System then shutdown.Patient was already asleep, no clinical consequences.A field service engineer was present but not driving the rosa.

Manufacturer Narrative

It was reported that a collision between the robot arm and the mayfield head holder occurred during a surgery.Dhr review and review of complaint history did not identify any contributory factors to the event.According to technical investigation the collision is confirmed.Review of the ifu and the training concluded that this collision could have been avoided by releasing the pedal as it is explained in the ifu.The root cause of this event is an use error.

Event Description

After finishing contactless registration on patient, the robot arm collided with the mayfield head holder during automatic move back to the home position.System then shutdown.Patient was already asleep, no clinical consequences.A field service engineer was present but not driving the rosa.

• 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: 8118845
• MDR Text Key: 128884436
• Report Number: 3009185973-2018-00333
• 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: 03/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2018
• 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: 02/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1