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U.S. Department of Health and Human Services

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

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MEDTECH SA ROSA SURGICAL DEVICE COMPUTER-ASSISTED SURGICAL DEVICE Back to Search Results
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.
 
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Brand NameROSA SURGICAL DEVICE
Type of DeviceCOMPUTER-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 Key6417448
MDR Text Key70355681
Report Number3009185973-2017-00058
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K101791
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
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 Received03/20/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberROSA 2.5.8
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/18/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/08/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 03/20/2017 Patient Sequence Number: 1
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