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U.S. Department of Health and Human Services

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

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MEDTECH SA ROSA SURGICAL DEVICE COMPUTER-ASSISTED SURGICAL DEVICE Back to Search Results
Model Number ROSA
Device Problem Unintended Movement (3026)
Patient Problem Skin Irritation (2076)
Event Date 09/14/2020
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. Unique identifier (udi) #: not applicable.
 
Event Description
The company clinical representative was informed by email that the rosa pushed on the patient skin. This happened during the registration validation. According to the description of the surgeon it was during a cooperative move to check the accuracy of the forehead. The surgeon placed the pointer on the forehead and the arm moved down and it was only with a lot of force possible to get the arm moved away from the patient head. The registration was aborted and redone. During the second time, the system was working normal. The surgery was continued. There was approximately 45 minutes delay, and the patient exhibited a red pressure mark after surgery.
 
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Brand NameROSA SURGICAL DEVICE
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 Key10612337
MDR Text Key209341501
Report Number3009185973-2020-00239
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K101791
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 01/19/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/01/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberROSA
Device Catalogue NumberROSAS00002
Device Lot Number2.5.8.4
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 Received01/18/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/22/2011
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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