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

Model Number ROSA ONE

Device Problem Malposition of Device (2616)

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

Event Date 01/20/2022

Event Type  Injury  

Event Description

It was reported that there was an inaccuracy of almost 10 mm for a posterior biopsy.Biopsy without outcome, had to be taken again.

Manufacturer Narrative

A full analysis of the device data logs and patient exams has been performed.This analysis concluded that the inaccuracy is confirmed for the biopsy trajectory with a deviation estimated at 7.33mm.No robotic error was found through the analysis.The root cause for this inaccuracy remains unknown but multiple causes are assumed: the registration was not optimal and multiple elements related to the reference image and its reconstruction in the software might have played a role in the surgery accuracy.It is possible that the head holder used had a play on its mounting and that the head moved during the surgery.The patient woke up after the first registration attempted.Micro-moves occurred so the registration was restarted but the head holder was not retightened again.It is then possible that the mounting was weakened.The analysis and the comparison with other similar cases on the same device on the past 3 months, did not permit to identify a repetitive pattern.Other similar procedures using same device and tools were performed for the past 3 months with correct accuracy.Unique identifier (udi) #: (b)(4).

• 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: 13585682
• MDR Text Key: 286009504
• Report Number: 3009185973-2022-00007
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K200511
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ROSA ONE
• Device Catalogue Number: ROSAS00201
• 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: 01/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/16/2020
• 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
• Patient Outcome(s): Other