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

Model Number ROSA 2.5.8

Device Problems Computer Software Problem (1112); Application Program Freezes, Becomes Nonfunctional (4031)

Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)

Event Date 08/13/2020

Event Type  malfunction  

Manufacturer Narrative

Udi# : not applicable.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 by the distributor that: 'ro16083 was installed in (b)(6); (b)(6) 2020.It appeared the same errors in 7 seeg surgeries.You can find log files in attachment.The date are (b)(6) 2020.As the doctor told me, the system would shut down almost every trajectory.'.

Manufacturer Narrative

Dhr review and review of complaint history did not identify any contributory factors to the event.A full analysis of the data logs for this event and for the other complaints related to the same issue/device has been performed and revealed that the reported event possibly results from a problem with the operation of the foot pedal due to electromagnetic interferences.The surgeon was reportedly using an electrocautery device during these surgeries, which could be at the origin of these electromagnetic interferences.A review of the ifus was performed and the user manual indicates that an usage of accessories, transducers and cables could result in increased electromagnetic emissions or decreased electromagnetic immunity of the robot and could result in improper operation.Based on available information, the root cause of the event could not be conclusively determined.Corrected data: - b4 date of this report - g4 date received by manufacturer - h2 if follow-up, what type - h3 device evaluated by manufacturer - h6 event problem and evaluation codes - h10 additional narratives/data.

Event Description

The chinese distributor reported that: 'ro16083 was installed at (b)(6) hospital on (b)(6) 2020.It appeared the same errors in 7 seeg surgeries.The dates are (b)(6) 2020 the system would shut down almost every trajectory.'.

• 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: 10799490
• MDR Text Key: 215052814
• Report Number: 3009185973-2020-00273
• 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: distributor
• Type of Report: Initial,Followup
• Report Date: 11/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ROSA 2.5.8
• Device Catalogue Number: ROSAS00005
• Device Lot Number: 2.5.8.4
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1