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

Model Number ROSA ONE

Device Problem Failure to Power Up (1476)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/26/2021

Event Type  Injury  

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.Unique identifier (udi) #: (b)(4).

Event Description

We are having a pattern of difficulties with our rosa machine at.These difficulties routinely follow any sort of 'maintenance' performed by the regional technicians.Today we had to cancel a surgery with the patient in the pre-operative area because after an hour of troubleshooting, the rosa machine still would not connect itself to the monitor to be functional.The rosa machine was working fine prior to its last 'maintenance' by the regional technician.We are now being told that the technician will not be able to attend to the repair until next week causing us to post-pone this needed surgery even further.

Manufacturer Narrative

It was reported that the rosa one device (b)(6) would not power up prior to a procedure.A company field service engineer investigated the system and diagnosed a problem with the robot stand computer.This investigation indicated that this computer motherboard was damaged and will not allow proper booting.Another computer was installed, which resolved the reported booting issue.Following this exchange, the field service engineer performed a complete preventive maintenance and final service verification to ensure proper utilization of the rosa one device (b)(6).Based on the investigation performed, the technical root cause of the event was determined to be due to a hardware component failure (computer motherboard).

Event Description

We are having a pattern of difficulties with our rosa machine.These difficulties routinely follow any sort of 'maintenance' performed by the regional technicians.Today we had to cancel a surgery with the patient in the pre-operative area because after an hour of troubleshooting, the rosa machine still would not connect itself to the monitor to be functional.The rosa machine was working fine prior to its last 'maintenance' by the regional technician.We are now being told that the technician will not be able to attend to the repair until next week causing us to post-pone this needed surgery even further.

• Brand Name: ROSA ONE
• 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: 12056043
• MDR Text Key: 258021150
• Report Number: 3009185973-2021-00155
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• PMA/PMN Number: K200511
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 08/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ROSA ONE
• Device Catalogue Number: ROSAS00203
• Device Lot Number: 3.1.4.1650
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other