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

Model Number ROSA ONE 3.1

Device Problem Image Display Error/Artifact (1304)

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

Event Date 03/16/2021

Event Type  malfunction  

Manufacturer Narrative

The device has not been evaluated yet for investigation purpose.Once the evaluation is performed, a follow-up medwatch report will be submitted.Unique identifier (udi) #: (b)(4).

Event Description

A failure of the pre-operative o-arm spin to merge with the pre-operative mri occurred.Efforts to improve the merge and re-calculate were ineffective.The pre-operative cta was effectively used to merge the o-arm spin (which contained the fiducials) and the impact to the surgery was limited to the ~2min delay to select the cta as a merge option.

Manufacturer Narrative

A full analysis of the patient folder has been performed and this analysis concluded that the merge of the pre-operative o-arm scan with the pre-operative mri was unsuccessful.This is a known issue when a ct scan is merged to an mri.Loading first the o-arm scan, and then merging automatically the mri with it would have been successful.A review of the ifus was performed and the user manual adequately indicates how to get a successful merge.Therefore, based on the investigation performed, the technical root cause of the event was determined to be a use error.

Event Description

A failure of the pre-operative o-arm spin to merge with the pre-operative mri occurred.Efforts to improve the merge and re-calculate were ineffective.The pre-operative cta was effectively used to merge the o-arm spin (which contained the fiducials) and the impact to the surgery was limited to the ~2min delay to select the cta as a merge option.

• 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: 11580682
• MDR Text Key: 247285863
• Report Number: 3009185973-2021-00087
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• PMA/PMN Number: K200511
• 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: 03/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2021
• 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: 03/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1