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

Model Number PLANNING STATION

Device Problem Patient Data Problem (3197)

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

Event Date 06/02/2021

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) #: unknown.

Event Description

It was reported that surgeon tried to load in patient folder from planning station, and was unable to load.When patient folder was attempted to be loaded, windows blue screen error occurred, with message 'page fault in nonpaged area'.The clinical representative (cr) arrived on site, and attempted to troubleshoot patient folder issues, and was unable to find.Ros file in patient folder.Surgeon needed to re-load patient series and re-plan procedure because planning laptop was unavailable and at other hospital location.Cr attempted to troubleshoot loading of series from usb and was unable to load series from folder which contained mri post-operative.Some of slices of series could be un-encrypted, but could not un-encrypt majority of series, and could therefore not troubleshoot full series.Cr could not open on business laptop or rosa robot, and was not able to view in rosanna software, iqview, or sante dicom editor software without causing page fault error.As a result, it was necessary to pull affected dicom series on usb from field.Delay of 2 hours for replanning, no patient involvement, patient was not in or under anesthesia, but delay of procedure start, patient had to wait in preoperative care until surgery was re-planned.Surgeon reported no issues or errors upon exporting the patient folder.

Event Description

It was reported that surgeon tried to load in patient folder from planning station, and was unable to load.When patient folder was attempted to be loaded, windows blue screen error occurred, with message 'page fault in nonpaged area'.The clinical representative (cr) arrived on site, and attempted to troubleshoot patient folder issues, and was unable to find.Ros file in patient folder.Surgeon needed to reload patient series and re-plan procedure because planning laptop was unavailable and at other hospital location.Cr attempted to troubleshoot loading of series from usb and was unable to load series from folder which contained mri post-operative.Some of slices of series could be un-encrypted, but could not un-encrypt majority of series, and could therefore not troubleshoot full series.Cr could not open on business laptop or rosa robot, and was not able to view in rosanna software, iqview, or sante dicom editor software without causing page fault error.As a result, it was necessary to pull affected dicom series on usb from field.Delay of 2 hours for replanning, no patient involvement, patient was not in or under anesthesia, but delay of procedure start, patient had to wait in preoperative care until surgery was re-planned.Surgeon reported no issues or errors upon exporting the patient folder.

Manufacturer Narrative

A full analysis of the data logs has been performed and this analysis concluded that the patient folder exported on the usb was corrupted.This caused a windows error each time the patient folder was attempted to be opened.However, the cause for the corruption could not be found.

• Brand Name: ROSA ONE
• Type of Device: COMPUTER-ASSISTED SURGICAL DEVICE
• Manufacturer (Section D): MEDTECH SAS; 432 rue du rajol; 900 rue du mas de verchant; mauguio, languedoc-roussillon 34130 ; FR 34130
• Manufacturer (Section G): MEDTECH SAS; 432 rue du rajol; 900 rue du mas de verchant; mauguio, languedoc-roussillon 34130 ; FR 34130
• Manufacturer Contact: jay sharma ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 12090620
• MDR Text Key: 259138917
• Report Number: 3009185973-2021-00159
• 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: Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PLANNING STATION
• Device Catalogue Number: ROSAS00369
• Device Lot Number: 3.1.4.1650
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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