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

Model Number POINTER PROBE (V3)

Device Problems Mechanical Problem (1384); Dent in Material (2526)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/02/2021

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.Unique identifier (udi) #: unknown.

Event Description

This event did not occur during surgery.During the brain accuracy check portion of the preventative maintenance for bs19060 brain robot, there was a failed accuracy check for the pointer probe ((b)(4)).It was tested again (2nd test) and the pointer probe passed.Upon further inspection, the company representative noted that there was slight deviation/dent in the ball of the pointer probe.It's very small, but this probably led to the original inaccuracy.

Manufacturer Narrative

It was reported that the rosas00315 pointer probe, s/n (b)(6) , failed the accuracy check portion of the preventative maintenance performed by the company representative.On the second attempt the pointer probe passed the accuracy check.The company representative performed a visual inspection of the pointer probe and noted that there was slight deviation/dent in the ball of the pointer probe.The reported issue can be confirmed based on the report of the company representative, trained to perform the preventative maintenances.However, the rosas00315 pointer probe, s/n (b)(6) , was not returned for investigation, and no pictures were provided.Therefore, and the root cause of the reported issue can not be determined.D4 unique identifier (udi) #: (b)(4).Corrected data: - b4 date of this report - d9 device availability - g3 date received by manufacturer - h2 if follow-up, what type - h3 device evaluated by manufacturer - h4 device manufacturer date - h6 adverse event problem - h10 additional narratives/data.

Event Description

This event did not occur during surgery.During the brain accuracy check portion of the preventative maintenance for bs19060 brain robot, there was a failed accuracy check for the pointer probe ((b)(6) ).It was tested again (2nd test) and the pointer probe passed.Upon further inspection, the company representative noted that there was slight deviation/dent in the ball of the pointer probe.It's very small, but this probably led to the original inaccuracy.

• 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
• Manufacturer (Section G): MEDTECH SA; zac eureka; 900 rue du mas de verchant; montpellier, languedoc-roussillon 34000 ; FR 34000
• Manufacturer Contact: jay sharma ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 11567237
• MDR Text Key: 242166144
• Report Number: 3009185973-2021-00083
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200511
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: POINTER PROBE (V3)
• Device Catalogue Number: ROSAS00315
• Device Lot Number: ROSA3-155A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/24/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1