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

Model Number ROSA ONE

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/14/2020

Event Type  malfunction  

Manufacturer Narrative

Udi# : (b)(4).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

After the seeg case on (b)(6) 2020, the surgeon called to tell that all of her electrodes were approximately 5 mm short of the target she set in the plan.We checked the patient folder from the day before, and the same situation occurred.This hospital has done 3 surgeries since having the robot and this occurred in all 3 patients.There was no injury to any of the patients.

Manufacturer Narrative

A full analysis of the data logs has been performed, including tests on the device, which revealed that the calibration file (.Dat) installed and used for the instrument holder mt-02-158 s/n (b)(6) was an obsolete version.The appropriate calibration file was then successfully installed on the robot, solving the issue.An applicative test confirmed that the calibration was conform.The technical root cause of the event was determined to be an incorrect calibration file used for the instrument holder.This manufacturing issue will be addressed through our non-conformity management process.Corrected data: - b4 date of this report - g4 date received by manufacturer - h2 if follow-up, what type - h3 device evaluated by manufacturer - h6 event problem and evaluation codes - h10 additional narratives/data.

Event Description

After the seeg case on tuesday, (b)(6) 2020, the surgeon called to tell that all of her electrodes were approximately 5 mm short of the target she set in the plan.We checked the patient folder from the day before and the same situation occurred.This hospital has done 3 surgeries since having the robot and this occurred in all 3 patients.There was no injury to any of the patients.

• 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: 10641752
• MDR Text Key: 210198650
• Report Number: 3009185973-2020-00246
• 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: 11/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: ROSAS00203
• Device Lot Number: 3.1.4.1650
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/23/2020
• Initial Date FDA Received: 10/07/2020
• Supplement Dates Manufacturer Received: 11/17/2020
• Supplement Dates FDA Received: 11/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1