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U.S. Department of Health and Human Services

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

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MEDTECH SAS ROSA ONE COMPUTER-ASSISTED SURGICAL DEVICE Back to Search Results
Model Number ROSA ONE
Device Problem Malposition of Device (2616)
Patient Problems Intracranial Hemorrhage (1891); Movement Disorder (4412); Speech Disorder (4415)
Event Date 11/22/2021
Event Type  Injury  
Manufacturer Narrative
Initial report : the device has not been evaluated yet for investigation purpose. Once the evaluation is performed, a follow-up medwatch report will be submitted. Unique identifier (udi) #: (b)(4).
 
Event Description
A symptomatic bleeding complication was reported on a trajectory deviation at the entry point for the fca' trajectory.
 
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Brand NameROSA ONE
Type of DeviceCOMPUTER-ASSISTED SURGICAL DEVICE
Manufacturer (Section D)
MEDTECH SAS
432 rue du rajol
mauguio, languedoc-roussillon 34130
FR 34130
Manufacturer (Section G)
MEDTECH SAS
432 rue du rajol
maugio, languedoc-roussillon 34130
FR 34130
Manufacturer Contact
jay sharma
1520 tradeport drive
jacksonville, FL 32218
9047414400
MDR Report Key13058933
MDR Text Key282605271
Report Number3009185973-2021-00187
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K200511
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/27/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/22/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberROSA ONE
Device Catalogue NumberROSAS00201
Device Lot Number3.1.5.28
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received01/18/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/16/2020
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: 12/22/2021 Patient Sequence Number: 1
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