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

Model Number OPTICAL DISTANCE SENSOR

Device Problem Calibration Problem (2890)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/23/2019

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. .

Event Description

The laser do not pass the calibration process when the offset calibration plate is fixed with the screw.Without using the screw, calibration is passed.

Event Description

The laser do not pass the calibration process when the offset calibration plate is fixed with the screw.Without using the screw, calibration is passed.

Manufacturer Narrative

The optical distance sensor was returned to manufacturing site on 02-jul-2019 along with its laser offset plate.The optical distance sensor was recalibrated and sent back to the customer on september 2019.The part was manufactured in 2013 and is in use since 2017.The root cause of the decalibration of the optical distance sensor has not been determined.

• Brand Name: ROSA SURGICAL DEVICE
• 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: 8780445
• MDR Text Key: 150701081
• Report Number: 3009185973-2019-00223
• 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: 10/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OPTICAL DISTANCE SENSOR
• Device Catalogue Number: ROSAS00016
• Device Lot Number: ROSA-075K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2019
• 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