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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 3.1
Device Problem Data Problem (3196)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/27/2020
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. (b)(4).
 
Event Description
The clinical representative (cr) assisted the surgeon an rns case on (b)(6) 2020. Before the case started, the surgeon mentioned to the cr that they experienced some issues loading the patient imaging the previous day (b)(6) 2020) onto the (b)(6) laptop. The surgeon stated that the imaging was attempted to be uploaded, but the progress stayed at zero percent for about ten minutes. After ten minutes, the surgeon removed the usb containing the patient imaging, and restarted the laptop. The surgeon attempted to load the imaging again the exact same way as before, but this time the imaging loaded quickly and worked fine. The cr loaded in the patient plan from the planning station to the robot to begin the case. Around 9:06am eastern time, the cr attempted to load in the bone fiducial ct imaging from a cd, to merge to the patient plan for registering. The cr experienced a similar imagery issue as to what the surgeon described from the day before. The cd imaging loaded into the rosa software, but when trying to load the needed series, it stayed at zero percent progress for a few minutes. The cr removed the usb, and tried again, but got the same result. The cr then tried the workaround of selecting the series through pacs/iq-view, and scanning/loading in the selected series from there. Once that was loaded into the rosa software, the series was selected to be loaded in, but this time it loaded quickly and correctly with no issue. The imaging was merged and surgery was continued. The patient was under anesthesia and no incision was made yet. The total delay was less than 30 minutes.
 
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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 Key10800108
MDR Text Key215015886
Report Number3009185973-2020-00295
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K200511
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 03/22/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/06/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberROSA ONE 3.1
Device Catalogue NumberROSAS00203
Device Lot Number3.1.4.1650
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/19/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/06/2018
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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