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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 COMPUTER FOR PRE-OP PLANNING
Device Problems Computer Software Problem (1112); Application Program Problem (2880); Data Problem (3196)
Patient Problem No Patient Involvement (2645)
Event Date 07/05/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4). It was reported that when trying to load in a large number of series from iqview into the software caused it to crash. Device history record review and complaint history review were not performed based on the low severity of this complaint. A full analysis of the data logs from the event has been performed, this analysis concluded that multiple crashes occurred during this case. Two occurred before exams loading from iq-view due to a software anomaly. The other crashes occurred after multiple reading errors of exams, unhandled by the software, due to an other software anomaly. The deletion of the temporary pacs folder was first compromised due to an other software anomaly, which occurred multiple times during the case. Deleting all unsupported exams directly in iq-view and selecting only exams of interest solved the issue.
 
Event Description
The company field service engineer (fse) received a phone call from surgeon on (b)(6) 2019 as he was planning his first case. Fse had already changed configuration issues in iqview previously due to configuration issues. The surgeon reported that he had tried to load in a large number of series from iqview into the rosa software, causing it to crash (message "rosanna. Exe stopped working"). Whenever he subsequently tried to load in anything from iqview into the rosa software, the rosanna software continued to crash, even after clicking "yes" to delete files in the temporary pacs folder. The fse suspected that the rosa software was not correctly deleting from the temporary pacs folder. The fse directed the surgeon to delete out the series manually from the maintenance side. Another try also led to a crash. The surgeon rebooted the rosa software, and noticed that the series he had previously loaded were still listed under the "network" tab on iqview. After deleting these series off of the iqview side, he was able to load his series (ct and mri) without any issues. This issue did not occur during a procedure and there was no patient involvement.
 
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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 Key9595134
MDR Text Key196074364
Report Number3009185973-2020-00009
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeUS
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 01/16/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/16/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberCOMPUTER FOR PRE-OP PLANNING
Device Catalogue NumberROSAS00349
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 Received01/15/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/15/2018
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

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