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U.S. Department of Health and Human Services

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

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MEDTECH SA ROSA ONE COMPUTER-ASSISTED SURGICAL DEVICE Back to Search Results
Model Number ROSA ONE
Device Problem No Display/Image (1183)
Patient Problem No Patient Involvement (2645)
Event Date 03/29/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4). It was reported that during 3d reconstruction the image would not display. Dhr review and review of complaint history did not identify any contributory factors to the event. According to technical investigation the 3d reconstruction failed after computing a new 3d segmentation threshold due to a dysfunction of the mutex for the 3d mesh. This is a known design defect.
 
Event Description
During surgeon training on (b)(6) 2019 an issue occurred with the 3d reconstruction feature in the rosanna software. When the slider was adjusted and the compute button was clicked the 3d head reconstruction would disappear from the screen and the tan color would no longer appear on the ct. If compute was clicked again the 3d reconstruction and tan color would still not be visible. If the slider was moved and compute was clicked, then the 3d reconstruction would appear again. This occurred every time that the field service engineer and surgeon tried to use this feature.
 
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Brand NameROSA ONE
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
1520 tradeport drive
jacksonville, FL 32218
9047414400
MDR Report Key8540347
MDR Text Key142787872
Report Number3009185973-2019-00144
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K182417
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/23/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/23/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberROSA ONE
Device Catalogue NumberN/A
Device Lot Number3.1.0.1276
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 Received03/29/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/13/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage
Removal/Correction NumberN/A

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