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

Model Number ROSA BRAIN 3.0

Device Problem Calibration Error (1078)

Patient Problem No Patient Involvement (2645)

Event Date 05/24/2018

Event Type  malfunction  

Manufacturer Narrative

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

Surgeon complained that touchscreen monitor was improperly calibrated.Cursor appeared approximately 6 inches to the left of touch position.Cst confirmed improper calibration, and ran touchscreen recalibration from windows control panel, which resolved the problem.This issue was likely a consequence of cst adjusting monitor settings on previous intervention.No clinical consequences, no patient involvement, no delay to surgery was reported.

Manufacturer Narrative

It was reported that the touchscreen of the monitor was improperly calibrated.A dhr review and a complaint history review were performed and did not identfy any contributory factors to the event.According to the complaint description the monitor settings were incorrectly adjusted by the field service engineer on 23 may 2018, the day before the issue was noticed.It is noted that the fse resolved the issue while correcting touchscreen monitor settings.The identified root cause of the issue is incorrect monitor parameters settings.(b)(4).

• Brand Name: ROSA BRAIN
• 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: 7569421
• MDR Text Key: 110589756
• Report Number: 3009185973-2018-00166
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• PMA/PMN Number: PK172444
• 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: 10/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ROSA BRAIN 3.0
• Device Catalogue Number: ROSA BRAIN
• Device Lot Number: 3.0.0.21
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1