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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC POWERED SURGICAL SOLUTIONS STEALTH MIDAS ORTHOPEDIC STEREOTAXIC INSTRUMENT

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MEDTRONIC POWERED SURGICAL SOLUTIONS STEALTH MIDAS ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Model Number EM200N
Device Problems Blocked Connection (2888); Output Problem (3005)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/14/2021
Event Type  malfunction  
Event Description
Surgery neuro coordinator notified central sterile processing manager that the medtronic stealth midas rex line-powered surgical power tool system motor that came back from repair the previous day was still not working. The burr would still not attach which was noticed while setting up for the case. There was no delay in the original intended procedure.
 
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Brand NameSTEALTH MIDAS
Type of DeviceORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
MEDTRONIC POWERED SURGICAL SOLUTIONS
4620 north beach st.
fort worth TX 76137
MDR Report Key11900701
MDR Text Key253151416
Report Number11900701
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
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 Received05/28/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberEM200N
Device Catalogue NumberEM200N
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/17/2021
Event Location No Information
Date Report to Manufacturer05/28/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage Unkown

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