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

Model Number ROSA

Device Problems Computer Software Problem (1112); No Display/Image (1183)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/08/2019

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

It was reported that there were two device shutdowns during the surgery.Then, the touchscreen was not touch-sensitive anymore.The mouse was working.

Manufacturer Narrative

It was reported that there were two device shutdowns during the surgery and that after the touchscreen was not touch-sensitive anymore, but the mouse was working.Event summary, device history record review and complaint history review were performed.With the available information it is not possible to confirm if the touchscreen was not touch-sensitive anymore as reported by the customer.It is probable that the monitor issues reported within the subject complaint are linked to a previous complaint (damaged isolation of the monitor usb-cable).According to the complaint description, two device shutdowns were reported.As part of the technical investigation only one issue was found.The software stopped working suddenly, when the robot was in 'home' position, due to either an application crash or operating system crash or an improper shutdown of the device.Not enough elements are provided to conclude about the root cause for this issue.

Event Description

It was reported that there were two device shutdowns during the surgery.Then, the touchscreen was not touch-sensitive anymore.The mouse was working.

• Brand Name: ROSA
• 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: 8408528
• MDR Text Key: 138434078
• Report Number: 3009185973-2019-00076
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• PMA/PMN Number: K101791
• 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: 09/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ROSA
• Device Catalogue Number: N/A
• Device Lot Number: 2.5.8.4
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1