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 Code Available (3191)

Event Date 10/20/2020

Event Type  Injury  

Manufacturer Narrative

Dhr review and review of complaint history did not identify any contributory factors to the event.A full analysis of the data logs has been performed, and this analysis led to the following observations : the function recalculate is supposed to provide a better merge solution following coarse manual adjustments.In the subject case, the function "recalculate" did not work as expected by the user since it did not permit to get a better result of the merge.The automatic merge feature of the rosa software does not find an adequate solution in all cases, this is why manual adjustments are still possible during the fusion process to allow fine tuning of the fusion until an acceptable result is obtained.Unique identifier (udi) #: (b)(4).

Event Description

Existing patient folder included mr, patient was positioned, fiducials placed, o-arm scan taken with patient on bed, not attached to rosa.O-arm ct scan was taken and imported via direct transfer, scan was merged with mr and resulted in inaccurate merge, with ct scan superior to mr.Manual adjustment was attempted, and re-calculation was done, but same result occurred.Patient was sent down to radiology for in-house ct, scan uploaded to pacs, merge was successful and accurate.Prior to acquisition of scan, ideal parameters were discussed with o-arm representative, seeg, 12 electrodes, delay of 40 minutes+.The patient was under anesthesia.

• 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: 10792250
• MDR Text Key: 214799529
• Report Number: 3009185973-2020-00282
• 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: 10/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• 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: 10/20/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/07/2018
• 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