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

Model Number ROSAP00045

Device Problem Calibration Problem (2890)

Patient Problem No Patient Involvement (2645)

Event Date 05/21/2019

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.  (b)(4).

Event Description

Field service engineer (fse) was present onsite at (b)(6) (br17030) to perform a planned preventive maintenance.When attempting to perform the laser accuracy checks, the laser was unable to calibrate with the calibration plate.Fse tried multiple times to reset laser, turned the robot off and on, wiped off the laser lens, and reinstalled the.Dat calibration file.The laser was never able to calibrate.Robot passed accuracy checks and applicative test with the pointer.No patient involvement.

Event Description

Field service engineer (fse) was present onsite at riley children's (br17030) to perform a planned preventive maintenance.When attempting to perform the laser accuracy checks, the laser was unable to calibrate with the calibration plate.Fse tried multiple times to reset laser, turned the robot off and on, wiped off the laser lens, and reinstalled the.Dat calibration file.The laser was never able to calibrate.Robot passed accuracy checks and applicative test with the pointer.No patient involvement.

Manufacturer Narrative

The optical distance sensor mt-02-183 s16054 was received at manufacturing site on 16-jan-2020.A calibration test was performed by a field service engineer and the calibration passed.However, the measurement of the offset plate was not correct.Therefore, it is assumed that either the laser offset plate was slightly bent, or the laser had a malfunction.None of those solutions could be confirmed through our visual inspection.

Event Description

Field service engineer (fse) was present onsite at (b)(6) children's ((b)(6)) to perform a planned preventive maintenance.When attempting to perform the laser accuracy checks, the laser was unable to calibrate with the calibration plate.Fse tried multiple times to reset laser, turned the robot off and on, wiped off the laser lens, and reinstalled the.Dat calibration file.The laser was never able to calibrate.Robot passed accuracy checks and applicative test with the pointer.No patient involvement.

Manufacturer Narrative

The part was received at manufacturing site on 16-jan-2020.Corrected data: - b4 date of this report; - d4 additional device information - catalog number; - d10 device availability; - g4 date received by manufacturer; - h2 if follow-up, what type; - h4 device manufacturer date; - h10 additional narrative/data.

• 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: 8706582
• MDR Text Key: 148311204
• Report Number: 3009185973-2019-00195
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• PMA/PMN Number: K151359
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 08/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ROSAP00045
• Device Catalogue Number: ROSAS00316
• Device Lot Number: ROSA3-277B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1