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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC BALL PROBE; INSTRUMENT, STEREOTAXIC
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MEDTRONIC NAVIGATION, INC BALL PROBE; INSTRUMENT, STEREOTAXIC Back to Search Results
Model Number 960-559
Medical Device Problem Code Material Integrity Problem (2978)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Evaluation of the returned probe found that the tip of the returned probe is visibly bent but with markers attached and fully seated, the probe returns good geometry and divot error readings.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
Medtronic received information from a manufacturer representative (rep) regarding a device being used outside of a procedure.It was reported that the passive planar probe's tip was bent.No patient harm was reported.
 
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Brand Name
BALL PROBE
Common Device Name
INSTRUMENT, STEREOTAXIC
Manufacturer (Section D)
MEDTRONIC NAVIGATION, INC
826 coal creek circle
louisville CO 80027
MDR Report Key8547421
Report Number1723170-2019-01969
Device Sequence Number1744697
Product Code HAW
UDI-Device Identifier00673978090153
UDI-Public00673978090153
Combination Product (Y/N)N
Initial Reporter StateNC
Initial Reporter CountryUS
PMA/510(K) Number
K972398
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,user f
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 04/24/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model Number960-559
Device Catalogue Number960-559
Device Lot Number170213
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/04/2018
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/23/2018
Initial Report FDA Received Date04/24/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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