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

Model Number ROSA ONE 3.1

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 02/02/2021

Event Type  malfunction  

Manufacturer Narrative

The metal plate underneath the support arm is used to index the lock system.This one fits in the oblong slots which allows the locking of the telescopic arm.The system was compliant at the time of its release and the assembled screws are coated with threadlocker and are tightened to 2.2n.M.It is unlikely that these screws could have fallen by themselves, someone certainly tried to disassemble the metal plate by unscrewing these 5 screws.The new screws were replaced on (b)(6) 2021 and no surgery was performed before this replacement.Unique identifier (udi) #: (b)(4).

Event Description

The clinical representative (cr) was present for a preventive maintenance.During the maintenance, cr noticed that the metal plate underneath the support arm had lost 5 screws, and was not completely seated on the support arm when the arm is not locked in place.When the arm is locked in place, the support arm is still rigid and does not move.The robot passed applicative and accuracy tests and is still in conformance for use during procedures.No patient involvement.

• 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: 11715391
• MDR Text Key: 247280889
• Report Number: 3009185973-2021-00112
• 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,health
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2021
• 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: ROSAS00203
• Device Lot Number: 3.1.4.1650
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/28/2019
• 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