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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 Malposition of Device (2616)
Patient Problem No Code Available (3191)
Event Date 10/02/2020
Event Type  Injury  
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 # (unique identifier (udi) #: (b)(4).
 
Event Description
Company clinical representative (cr) was present for a monteris ablation case. The surgeon planned one trajectory for a fairly superficial lesion in the parietal lobe. Fiducial registration was performed by getting an o-arm scan and merging it to the preoperative mri. Both surgeon and cr looked at the merge and confirmed accuracy. After placing the trajectory, the patient was detached from rosa and the mri machine was brought in to begin the ablation. When the first intraoperative mri was taken, however, it showed that the trajectory was several millimeters inferior than the planning target point. As a result, surgeon was not able to ablate as much as the lesion as he wanted. Surgeon and cr again looked at the merge between the o-arm scan and the preoperative mri and did not believe that the merge could have caused the inaccuracy. Surgeon did not notice any head shift, the trajectory did not seem to skive during drilling or bolt placement, and the fiducial registration gave a good rms value that both the cr and surgeon found acceptable. The intraoperative mri scan showing the placement of the fiber would not merge correctly to the preoperative mri, but the cr retrieved it for the cht team to try to merge into the plan themselves. No known impact to patient, error occurred after first incision and patient was already under anesthesia, no delay to case.
 
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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 Key10654601
MDR Text Key210657893
Report Number3009185973-2020-00260
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 Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/09/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberROSA ONE
Device Catalogue NumberROSAS00203
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 Received01/15/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/17/2018
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

Patient Treatment Data
Date Received: 10/09/2020 Patient Sequence Number: 1
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