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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 Malposition of Device (2616)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/04/2021
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. Unique identifier (udi) #: (b)(4).
 
Event Description
It was reported that during a case at ochsner medical center, an issued occurred with the fixation of the arm in axial position. While performing a visualase case, we were positioned on trajectory 1 in axial position. The surgeon drilled, and then inserted the pmt visualase bolt into said trajectory. We then exchanged adapters to the rosa 3. 2 metal drill bit to take the measurement for the laser fiber. Once this was done, the surgeon recognized that the trajectory was slightly below the implanted bolt. Following this, the surgeon was able to physically push the robot arm upwards (specifically, out of axial position) at minimum 4/5mm. This was while the robot arm was locked in axial position along the target. The surgeon immediately recognized that the arm was not locked in axial. A confirmation spin was completed, and the trajectory was only 2mm off target so the case was completed.
 
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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
MDR Report Key12745650
MDR Text Key279882970
Report Number3009185973-2021-00180
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
Type of Report Initial
Report Date 11/03/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/03/2021
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 NumberUNKNOWN
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/04/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/16/2018
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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