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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 Data Problem (3196)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/06/2021
Event Type  malfunction  
Manufacturer Narrative
Udi# : (b)(4). A full analysis of the data logs has been performed and this analysis showed that the patient folder did not appear in the list of available patient folders because the post-operative dicom did not contain the "series date" field, which is a required by the software. This is a known issue that will be addressed through the continuous improvement process of our products.
 
Event Description
The surgeon texted the clinical representative (cr), stating that the patient folder of the dbs patient from sunday would be missing on the laptop. Cr checked and found the patient folder in maintenance. The surgeon had imported a postop ct. In the. Ros file the [serie_date] was empty. Cr filled the empty field and recalculated the crc. Patient folder is now accessable.
 
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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 Key12179935
MDR Text Key261911711
Report Number3009185973-2021-00172
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeIS
PMA/PMN Number
K200511
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 07/16/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/16/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberROSA ONE
Device Catalogue NumberROSAS00252
Device Lot Number3.1.5.1664
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 Received07/06/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/04/2020
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

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