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

Model Number ROSAS00132

Device Problem Bent (1059)

Patient Problem No Patient Involvement (2645)

Event Date 12/13/2017

Event Type  malfunction  

Manufacturer Narrative

The pointer probe from device (b)(4) has not been evaluated yet for investigation purpose.Once the evaluation will be performed, a follow-up medwatch report will be submitted.The device model rosa one is not fda cleared but is similar to the device rosa brain 3.0, classified haw and cleared under k151359.

Event Description

It was reported that the pointer probe is bent and need to be replaced.

Manufacturer Narrative

It was reported that the navigation probe (b)(4) was bent.A request for product return has been completed however the fse confirmed by mail that the part was not found at the customer site.In addition, no product return has been recorded for this part at the manufacturer site.Therefore the navigation probe (b)(4) is not available for investigation purpose.The root cause of the issue cannot be determined precisely however the most probable root cause is damage during use.Unique identifier (udi) # : (b)(4).Corrected data: date of this report, manufacturer email, additional device information, device availability, office contact manufacturing site, date received by manufacturer, if follow-up, what type, device evaluated by manufacturer, evaluation code.

• 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
• MDR Report Key: 7177723
• MDR Text Key: 96821655
• Report Number: 3009185973-2018-00003
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 10/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ROSAS00132
• Device Catalogue Number: NAVIGATION PROBE
• Device Lot Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1