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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 03/26/2021
Event Type  malfunction  
Manufacturer Narrative
The device has not been evaluated yet for investigation purpose. Once the evaluation is performed, a follow-up medwatch report will be submitted. Udi# : (b)(4).
 
Event Description
After the endoscopy case today, the surgeon asked the clinical representative (cr) to check the pacs connection. He was not able any more to get images sent to iqview. The cr checked with pacs tech whats the issue. It was found that a bad network setup. No gateway entered over dhcp. Switching to static ip settings solved this. After this pacs tech was able to sent images. Iqview database didn´t show images. Iqview log showed access denied for iqview db. The cr checked on the harddisc and found dicom data, which was retrieved in dicom folder. Rosanna and iqview didn´t show these dicoms. System almost unusable like this. Planning over cd drive is extremely slow. Furthermore the surgeon had issues to load a patient from usb. Rosanna showed data to load, but when selecting to load, error message, dicom cannot be loaded because the patient name had a "ü".
 
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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 Key11698781
MDR Text Key256560934
Report Number3009185973-2021-00108
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
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,Followup
Report Date 10/29/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/21/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberROSA ONE
Device Catalogue NumberROSAS00209
Device Lot Number3.1.4.1650
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 Received10/29/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/30/2018
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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