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

Model Number ROSA ONE 3.1

Device Problem Program or Algorithm Execution Failure (4036)

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

Event Date 02/13/2022

Event Type  malfunction  

Manufacturer Narrative

A full analysis of the data logs has been performed and concluded that rms values superior to 4mm were systematically obtained during the case.This was due to the pointer probe used, that was found non-compliant during later maintenance tests due to a deformation of the tip of the pointer probe.Udi#: (b)(4).

Event Description

The customer reported that the registration both with frame and fiducials does not work.The result is a rms superior to 4 mm which is superior to specifications.The system is currently not working, surgery had to be aborted and rescheduled.

• Brand Name: ROSA ONE
• Type of Device: COMPUTER-ASSISTED SURGICAL DEVICE
• Manufacturer (Section D): MEDTECH SAS; 432 rue du rajol; mauguio, languedoc-roussillon 34130 ; FR 34130
• Manufacturer (Section G): MEDTECH SAS; 432 rue du rajol; mauguio, languedoc-roussillon 34130 ; FR 34130
• Manufacturer Contact: jay sharma ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 13619810
• MDR Text Key: 288028345
• Report Number: 3009185973-2022-00014
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: K200511
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ROSA ONE 3.1
• Device Catalogue Number: ROSAS00252
• Device Lot Number: 3.1.5.28
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/04/2020
• 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