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U.S. Department of Health and Human Services

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

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MEDTECH SA ROSA BRAIN COMPUTER-ASSISTED SURGICAL DEVICE Back to Search Results
Model Number ROSA BRAIN
Device Problem Calibration Problem (2890)
Patient Problem No Code Available (3191)
Event Date 12/18/2017
Event Type  Injury  
Manufacturer Narrative
The investigation on the data log has been performed and has not shown any failure, the device operated within specification. The root cause is a user error, who did not follow the ifu by not checking the patient's head proper attachment in the head holder before he started the case.
 
Manufacturer Narrative
The device has not been evaluated yet for investigation purpose. Once the evaluation will be performed, a follow-up medwatch report will be submitted.
 
Event Description
Following fiducial registration with a good accuracy value, surgeons used pointer probe to mark entry points of 4 trajectories. Multiple inaccuracies occured during surgery with instrument holder. Estimated loss was approximately 60 minutes.
 
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Brand NameROSA BRAIN
Type of DeviceCOMPUTER-ASSISTED SURGICAL DEVICE
Manufacturer (Section D)
MEDTECH SA
zac eureka
900 rue du mas de verchant
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
1520 tradeport drive
jacksonville, FL 32218
9047414400
MDR Report Key7145458
MDR Text Key250773729
Report Number3009185973-2017-00833
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PK151359
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,Followup
Report Date 01/25/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/26/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberROSA BRAIN
Device Catalogue NumberN/A
Device Lot NumberN/A
Other Device ID NumberN/A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/25/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/24/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 12/26/2017 Patient Sequence Number: 1
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