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

Model Number ROBOT ARM

Device Problem Unintended Arm Motion (1033)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/22/2018

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

Surgeon is concerned that the robot arm allows too much unwanted movement when drilling and placing the ablation bolt, which is causing placement error.This unwanted movement happens when the robot arm is extended and the vigilance device is off (i.E.The robot is not powered).Cst noticed that there may be an abnormal amount of movement.

Manufacturer Narrative

It was reported that it was noticed that the robot arm allowed too much movements when drilling or placing bolts.Dhr review did not identify any contributory factors to the event.Review of complaint history showed that 2 complaints for inaccuracies were received for this device.The investigation on those complaints showed that a failure of the device was not the cause of the inaccuracies.According to technical investigation there is no test available to check if the robot arm is out of specifications.However the event is confirmed by the surgeon, the field service engineer on site and by r&d and field service department through the review of videos of the event.The device ro15064 was removed from the hospital as part of zfa 2018-00194 and is no longer used.Incoming complaints for this device will be monitored.Corrected data: - b4 date of this report - d4 additional device information - catalog number - g1-2 contact office - manufacturing site - g4 date received by manufacturer (completion of the technical investigation) - h2 if follow-up, what type - h3 device evaluated by manufacturer - h6 evaluation code - h7 remedial action.

Event Description

Surgeon is concerned that the robot arm allows too much unwanted movement when drilling and placing the ablation bolt, which is causing placement error.This unwanted movement happens when the robot arm is extended and the vigilance device is off (i.E.The robot is not powered).Field service engineer noticed that there may be an abnormal amount of movement.

• 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
• MDR Report Key: 7369472
• MDR Text Key: 103457204
• Report Number: 3009185973-2018-00104
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• PMA/PMN Number: PK101791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 12/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ROBOT ARM
• Device Catalogue Number: ROSAP00017
• Device Lot Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1