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

Model Number POINTER PROBE (V3)

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/28/2021

Event Type  malfunction  

Manufacturer Narrative

This part was returned for investigation.This part is calibrated, and the device was conform upon leaving the manufacturing site.However, the pointer should be perpendicular to its extension, while the visual inspection clearly revealed that the pointer was bent.The origin of the damage to the pointer remains unknown.An unintended shock on the thin end of the probe remains the most probable hypothesis (use error).This instrument will be replaced for the next surgeries.Unique identifier (udi) #: (b)(4).Mt-02-157.(b)(4).

Event Description

It was reported that the pointer probe was bent.No patient impact and no known inaccuracy issue.

Event Description

It was reported that the pointer probe was bent.No patient impact and no known inaccuracy issue.

Manufacturer Narrative

The udi was incorrect in initial report.Correct udi: (b)(4).

• 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: 11320602
• MDR Text Key: 232267947
• Report Number: 3009185973-2021-00038
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• PMA/PMN Number: K182417
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: POINTER PROBE (V3)
• Device Catalogue Number: ROSAS00315
• Device Lot Number: MT-02-157
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1