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

Model Number ROSA ONE

Device Problem Data Problem (3196)

Patient Problem No Patient Involvement (2645)

Event Date 04/27/2018

Event Type  malfunction  

Manufacturer Narrative

The device model rosa one is not fda cleared but is similar to the device rosa brain 3.0, classified haw and cleared under k151359/k172444.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

It was reported that the robot was unable to load the patient data just before a surgery.This data was previously exported from the computer for pre-op planning.Consequently, the surgery planning had to be redone on the robot.There was a reported delay of about 10 minutes to redo the planning and restart the system.

Manufacturer Narrative

It was reported that the surgeon needed to re-do the planning on the rosa pc because he could not load the patient data previously exported from the planning station.A dhr review and a complaint history review were performed and did identify 1 similar complaint which had occurred one week before.A full analysis of data log has been performed and indicates that the cause of the issue is a discrepancy between options installed on the rosa pc and the computer for pre-op planning.Based on the technical investigation performed the root cause identified is a manufacturing non-conformity which is being further investigated internally.Unique identifier (udi)#: (b)(4).Corrected data: date of this report.Date received by manufacturer.If follow-up, what type.Device evaluated by manufacturer.Evaluation code.

• 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: 7513531
• MDR Text Key: 108242030
• Report Number: 3009185973-2018-00145
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• PMA/PMN Number: PN/A
• 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: 08/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ROSA ONE
• Device Catalogue Number: N/A
• Device Lot Number: 3.1.0.1276
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1