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

Model Number ROSA

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Code Available (3191)

Event Date 03/02/2018

Event Type  Injury  

Manufacturer Narrative

The device (b)(4) has not been evaluated yet for investigation purpose.Once the evaluation will be performed, a follow-up medwatch report will be submitted.No code available' was selected as patient code as the surgery has been aborted, according to our internal guideline it is considered as a serious injury.

Event Description

It was reported that when starting the contactless registration, at initialization of the system, a message appeared "impossible to connect with robot arm".After few tries, they decided to cancel the surgery using the device and device was put out of the or.A field service engineer that was present was informed by the medical team that the rosa device is not plug on a security wall outlet during surgeries.

Manufacturer Narrative

A dhr and a complaint history review were performed and did not identify any contributory factors to the event.The data log analysis performed indicates the forces thread failed to start indicating that the robot could not connect to the force sensor.However the root cause for this error cannot be determined.The cst was present at the time of the event and solved the issue after the surgery was aborted.The device is still used at the costumer location.A review of preventative maintenance shows that no anomalies were present and the device functioned as intended.The wire connections were checked and found no issue.

• 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: 7319696
• MDR Text Key: 101689339
• Report Number: 3009185973-2018-00064
• 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
• Type of Report: Initial,Followup
• Report Date: 06/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ROSA
• Device Catalogue Number: N/A
• Device Lot Number: ROSA 2.5.8.4
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/02/2018
• Initial Date FDA Received: 03/07/2018
• Supplement Dates Manufacturer Received: 06/12/2018
• Supplement Dates FDA Received: 06/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other