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

Model Number ROSA PLANNING STATION (V3)

Device Problem Problem with Software Installation (3013)

Patient Problem No Patient Involvement (2645)

Event Date 10/14/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On (b)(6), the field service engineer (fse) tried to install pacs on rosa planning station.After configuring and connecting the planning station to an ethernet wire, the fse manage to load a patient folder in iq-view 3.0 but impossible to retrieve it into pacs temporary file by clicking on "retrieve" button.At that moment a iq message appear "errors occurred while retrieving data from pacs." the fse compared iq view settings of this planning station to another rosa planning station which is working well.No difference.

Manufacturer Narrative

During the maintenance performed on (b)(6) 2020, it was found that dicom could not be retrieved from iq-view because the computer name declared on the it server was not the correct one.The name was corrected and the retrieving function is now functional on the planning station.

Event Description

On 14th october, the field service engineer (fse) tried to install pacs on rosa planning station.After configuring and connecting the planning station to an ethernet wire, the fse manage to load a patient folder in iqview 3.0 but impossible to retrieve it into pacs temporary file by clicking on "retrieve" button.At that moment a iq message appear "errors occurred while retrieving data from pacs." the fse compared iq view settings of this planning station to another rosa planning station which is working well.No difference.

• 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: 9313929
• MDR Text Key: 205310133
• Report Number: 3009185973-2019-00389
• 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
• Type of Report: Initial,Followup
• Report Date: 09/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: ROSA PLANNING STATION (V3)
• Device Catalogue Number: ROSAS00349
• Device Lot Number: 3.1.0.1276
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/14/2019
• Initial Date FDA Received: 11/13/2019
• Supplement Dates Manufacturer Received: 09/08/2020
• Supplement Dates FDA Received: 09/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1