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

Model Number COMPUTER FOR PRE OP PLANNING

Device Problem Image Display Error/Artifact (1304)

Patient Problem No Patient Involvement (2645)

Event Date 02/25/2019

Event Type  malfunction  

Manufacturer Narrative

Udi#: (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

Surgeon stated that the ct and mri scans did not merge correctly in the automatic merge in the planning station.The surgeon had to use the manual arrows to adjust the image by 0.5mm to 1mm.He stated that he was satisfied with the results; however, there were still a couple areas on the image where the blood vessels on the mri and ct did not completely align.Both images were taken on the same day - (b)(6) 2018.The surgeon stated that due to the merge issues he spent extra time adjusting the merge and replanning each trajectory on the ct scan.As the planning was performed prior to surgery, there was no patient involvement.

Manufacturer Narrative

It was reported that after automatic fusion and manual adjustments on the computer for pre op planning, the merge of mri and ct was still not perfect.Dhr review and review of complaint history did not identify any contributory factors to the event.According to technical investigation there was no malfunction of the device.User should have continued the manual adjustments to obtain a perfect result.As the user manual provides all necessary information concerning the fusion adjustment, this issue can be considered as a use error.Corrected data: date of this report.Date received by manufacturer.If follow-up, what type.Device evaluated by manufacturer.Event problem and evaluation codes.

Event Description

Surgeon stated that the ct and mri scans did not merge correctly in the automatic merge in the planning station.The surgeon had to use the manual arrows to adjust the image by 0.5mm to 1mm.He stated that he was satisfied with the results; however, there were still a couple areas on the image where the blood vessels on the mri and ct did not completely align.Both images were taken on the same day - (b)(6) 2018.The surgeon stated that due to the merge issues he spent extra time adjusting the merge and replanning each trajectory on the ct scan.As the planning was performed prior to surgery, there was no patient involvement.

• Brand Name: ROSA BRAIN
• 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: 8452186
• MDR Text Key: 139870170
• Report Number: 3009185973-2019-00079
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• PMA/PMN Number: K172444
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 05/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: COMPUTER FOR PRE OP PLANNING
• Device Catalogue Number: ROSAS00369
• Device Lot Number: 3.0.0.20
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1