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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 Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/26/2021
Event Type  malfunction  
Manufacturer Narrative
Unique identifier (udi) #: (b)(4). A full analysis of the data logs has been performed. This analysis concluded that the inaccuracy at the entry point is confirmed for all fourteen trajectories implanted. The cause for the inaccuracy could not be determined. No dysfunction was identified on the device. The device passed the maintenance tests that were performed before and after the case.
 
Event Description
The company representative (cr) assisted the surgeon for an seeg case using bs (b)(4). After the case was complete, a few post-op scans were obtained from the o-arm, and merged into the software. The merge appeared to have worked correctly. It was found that all of the laterally placed electrodes appeared to be off at entry by more than 4mm. The surgeon noted that a shift most likely did not occur, the patient was very secure with the leksell frame, so the surgeon is worried that the accuracy was due to something with rosa. The two insular electrodes appeared to be more accurate, and these were placed obliquely (versus laterally). Contactless registration was used, and there were no errors during the registration, everything appeared to be correct. Verification also passed. The cr looked at the most recent preventive maintenance forms for the last four accuracy tests on form f-019, and it appears the x error appears to be around 2mm for each test, and then y and z appear to be anywhere from 1. 5-1. 7mm of error. The serial number for the laser is (b)(4), so the laser itself is almost 5 years old. The surgeon requested that an investigation be performed asap, since the surgeon is concerned about accuracy for their future cases.
 
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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 Key11869238
MDR Text Key265352423
Report Number3009185973-2021-00126
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
Type of Report Initial
Report Date 05/17/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/24/2021
Is this an Adverse Event Report? No
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?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/26/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/13/2018
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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