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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC GUIDE BIOPSY; INSTRUMENT, STEREOTAXIC
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MEDTRONIC NAVIGATION, INC GUIDE BIOPSY; INSTRUMENT, STEREOTAXIC Back to Search Results
Model Number 960-539
Medical Device Problem Codes Material Integrity Problem (2978); Output Problem (3005)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 02/10/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
No parts have been returned for analysis.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
Medtronic received information regarding a navigation system used outside of a procedure.It was reported that the guide biopsy was defective.No patient involvement was reported.Additional information: it was reported that the biopsy needle would not lock.
 
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Brand Name
GUIDE BIOPSY
Common Device Name
INSTRUMENT, STEREOTAXIC
Manufacturer (Section D)
MEDTRONIC NAVIGATION, INC
826 coal creek circle
louisville CO 80027
MDR Report Key11425322
Report Number1723170-2021-00595
Device Sequence Number2856951
Product Code HAW
UDI-Device Identifier00681490991520
UDI-Public00681490991520
Combination Product (Y/N)N
Initial Reporter CountryFR
PMA/510(K) Number
K954276
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date (Section B) 03/05/2021
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 Number960-539
Device Catalogue Number960-539
Device Lot Number161212
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/15/2021
Initial Report FDA Received Date03/05/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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