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

Model Number ROSA 2.5.8

Device Problem Positioning Problem (3009)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 02/18/2015

Event Type  Injury  

Manufacturer Narrative

The device ro 14 038has been inspected for investigation purpose.The tests performed confirmed that a not detected shift between the information displayed in the navigation software and the actual patient anatomy, potentially caused by head motion inside the head holder due to high thickness of the patient's skin and handling of the patient head during surgery.The internal complaint reference is the following: (b)(4).

Event Description

It has been reported that the surgeon merged the post-op ct image and found that on all but one trajectory, there was a significant discrepancy in the plan and in the true position of electrodes.There appears to be, according to the surgeon, a consistent 5mm cephalad entry point consistent with the plan.Electrodes, according to the surgeon, appear to be parallel to the plan and the target points differ as well.One electrode is inferior to plan.The surgeon is requesting support to analyze the reason for placement results and does not planning on replacing electrodes at this time.After operation patient is "very dysarthric." patient has experienced a stroke prior to this operation.No seizures have yet been recorded in the emu following surgery, so no epileptiform activity has been observed in the depth electrodes.

• Brand Name: ROSA SURGICAL DEVICE
• 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 ; zac eureka; 900 rue du mas de verchant; montpellier, languedoc-roussillon 34000 ; FR 34000 ; 7414400
• MDR Report Key: 6417448
• MDR Text Key: 70355681
• Report Number: 3009185973-2017-00058
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 03/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ROSA 2.5.8
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/18/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/08/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 52 YR