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

Model Number FORCE SENSOR 2 ROBOT ARM CABLE

Device Problems Disassembly (1168); Unintended Collision (1429)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/13/2017

Event Type  malfunction  

Manufacturer Narrative

The device has not been evaluated yet for investigation purpose.Once the evaluation will be performed, a follow-up medwatch report will be submitted.

Event Description

During the surgery, the robot arm was moved to the trajectory and collided with the rosa cover.The impact occurred at the point where the force sensor cable is plugged into the robot arm.Later during the surgery, the force sensor cable was again partially pulled out of the socket while the robot arm was moved to the trajectory because the sterile drape was tied too tightly around the robot arm.The surgeon then loosened the draping and plugged the cable back into the socket.The robot arm was then able to continue to the trajectory.When the surgery was finished the robot arm was moved back to the home position, a communication failure message appeared and rosa shut down, as the force sensor cable was completely removed from the socket.The robot arm was unable to be moved back into park position because the cable of the force sensor was unplugged.

Manufacturer Narrative

Investigation indicated that the root cause of the reported event is user error.The ifu contains instructions for the user to remain attentive during robot arm movements and to release the vigilance device to stop the robot arm movement if needed.In this specific case the surgeon did not follow those instructions and failed to release the vigilance device to prevent the collision.The device shutdown that occurred after the collision is a normal device behavior.The connector of the force sensor cable have been damaged in the collision, and the cable was not able to be reinserted.Therefore the interface block was replaced for repair purposes.

Manufacturer Narrative

This complaint is being remediated under an issue evaluation: complaints item numbers remediation.The item number was updated, the concerned medical device was the force sensor cable and not the rosa robot.

Event Description

During the surgery, the robot arm was moved to the trajectory and collided with the rosa cover.The impact occurred at the point where the force sensor cable is plugged into the robot arm.Later during the surgery, the force sensor cable was again partially pulled out of the socket while the robot arm was moved to the trajectory because the sterile drape was tied too tightly around the robot arm.The surgeon then loosened the draping and plugged the cable back into the socket.The robot arm was then able to continue to the trajectory.When the surgery was finished the robot arm was moved back to the home position, a communication failure message appeared and rosa shut down, as the force sensor cable was completely removed from the socket.The robot arm was unable to be moved back into park position because the cable of the force sensor was unplugged.

• Brand Name: ROSA SURGICAL DEVICE
• 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
• Manufacturer (Section G): MEDTECH SA; zac eureka; 900 rue du mas de verchant; montpellier, languedoc-roussillon 34000 ; FR 34000
• Manufacturer Contact: jay sharma ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 6666212
• MDR Text Key: 78392327
• Report Number: 3009185973-2017-00644
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK101791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Inspection
• Type of Report: Initial,Followup,Followup
• Report Date: 04/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FORCE SENSOR 2 ROBOT ARM CABLE
• Device Catalogue Number: ROSAS00474
• Device Lot Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/15/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/08/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1