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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 Computer Software Problem (1112)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/05/2019
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.  the device model rosa one spine application is not fda cleared but is similar to the device rosa spine 1.0, classified olo and cleared under k151511.
 
Event Description
The field service engineer (fse) was contacted on tue.March 5th regarding a communication failure which happened on rosa one spine at the beginning of a surgery.The surgery has been performed with a 10-15min delay, with navigation.The fse went on site on tuesday evening to troubleshoot the system, and found out the camera firmware was corrupted, preventing it from working.The system was fully functional after the camera software reinstallation.
 
Event Description
The field service engineer (fse) was contacted on tue.March 5th regarding a communication failure which happened on rosa one spine at the beginning of a surgery.The surgery has been performed with a 10-15min delay, with navigation.The fse went on site on tuesday evening to troubleshoot the system, and found out the camera firmware was corrupted, preventing it from working.The system was fully functional after the camera software reinstallation.
 
Manufacturer Narrative
Corrected data: - b4 date of this report.- g4 date received by manufacturer.- h2 if follow-up, what type.- h6 event problem and evaluation codes.- h10 additional narratives/data.H6_it was noticed that the conclusion provided in the last mdr sent report was related to a design defect while the root cause of the event can not be determined due to insufficient information.For this reason, it was decided to send a final report in order to modify the information.To remind that according to the complaint description, a communication error occurred at the beginning of a spinal surgery due to a corruption of the firmware of the camera.After the re-installed of the camera software, the system was fully functional.
 
Event Description
The field service engineer (fse) was contacted on tue.March 5th regarding a communication failure which happened on rosa one spine at the beginning of a surgery.The surgery has been performed with a 10-15min delay, with navigation.The fse went on site on tuesday evening to troubleshoot the system, and found out the camera firmware was corrupted, preventing it from working.The system was fully functional after the camera software reinstallation.
 
Manufacturer Narrative
Udi : (b)(4).Corrected data: - b4 date of this report - d4 unique identifier (udi) number - g4 date received by manufacturer - h2 if follow-up, what type - h3 device evaluated by manufacturer - h6 event problem and evaluation codes - h10 additional narratives/data according to the complaint description, a communication error occurred at the beginning of a spinal surgery due to a corruption of the firmware of the camera.After the re-installed of the camera software, the system was fully functional.The device model rosa one spine application was not fda cleared at the time of the event but was similar to the device rosa spine 1.0, classified olo and cleared under k151511.
 
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Brand Name
ROSA ONE
Type of Device
COMPUTER-ASSISTED SURGICAL DEVICE
Manufacturer (Section D)
MEDTECH SA
zac eureka
900 rue du mas de verchant
montpellier, languedoc-roussillon 34000
FR  34000
MDR Report Key8477006
MDR Text Key141025365
Report Number3009185973-2019-00113
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup
Report Date 02/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/03/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberROSA ONE 3.1
Device Catalogue NumberROSA ONE CAMERA STAND
Device Lot Number3.1.0.1276
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received02/27/2020
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
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