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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTECH SA ROSA BRAIN COMPUTER-ASSISTED SURGICAL DEVICE

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MEDTECH SA ROSA BRAIN COMPUTER-ASSISTED SURGICAL DEVICE Back to Search Results
Model Number ROSA BRAIN
Device Problem No Display/Image (1183)
Patient Problem No Patient Involvement (2645)
Event Date 02/27/2019
Event Type  malfunction  
Manufacturer Narrative
Udi#: (b)(4). The device has not been evaluated yet for investigation purpose. Once the evaluation is performed, a follow-up medwatch report will be submitted.
 
Event Description
Surgeon attempted to load post-op ct from o-arm. Merge was not good, so surgeon attempted to adjust merge, and accidentally confirmed post-op merge before completed. Surgeon deleted the series, and attempted to restart and reload the series. "impossible to load exam" error recurred. Unable to log out of exam manager or rosanna software. Needed to restart rosa pc to proceed. Attempted to repeat, and still unable to load. "impossible to load exam" error occurred whenever attempting to load ct or cta. Used other software instead of rosanna to complete post-op analysis. Additionally, neurologist was unable to look at merge exams for analysis. No patient was involved in this event, it occurred post-operatively.
 
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Brand NameROSA BRAIN
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 Key8456314
MDR Text Key140007509
Report Number3009185973-2019-00105
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K172444
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 06/10/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/27/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberROSA BRAIN
Device Catalogue NumberN/A
Device Lot Number3.0.0.21
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 Received05/14/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/13/2018
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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