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

Model Number OPTICAL DISTANCE SENSOR

Device Problem Calibration Problem (2890)

Patient Problem No Patient Involvement (2645)

Event Date 10/12/2018

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.(b)(4).

Event Description

It was reported that the optical distance sensor failed the accuracy checks performed by a company representative part of the preventative maintenance.

Manufacturer Narrative

The optical distance sensor and the associated offset plate were tested at the manufacturing site and no accuracy issue was detected.Therefore those parts were sent back to the hospital were they passed the accuracy test successfully.Since this date no further related issues were reported.The cause of the event can not be determined.Event summary, device history record review and complaint history review did not identify contributing factors.

Event Description

It was reported that the optical distance sensor failed the accuracy checks performed by a company representative part of the preventative maintenance.

• 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: 8051191
• MDR Text Key: 126644648
• Report Number: 3009185973-2018-00292
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• PMA/PMN Number: K172444
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 04/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: OPTICAL DISTANCE SENSOR
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1