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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC CART 9733856 S7 STAFF ASSEMBLED 110V INSTRUMENT, STEREOTAXIC

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MEDTRONIC NAVIGATION, INC CART 9733856 S7 STAFF ASSEMBLED 110V INSTRUMENT, STEREOTAXIC Back to Search Results
Model Number 9733856
Device Problem Output Problem (3005)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/26/2020
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical products: product id: 9733068, serial/lot #: (b)(4), ubd: 04-feb-2022, udi#: (b)(4). Product id: 9735585, software version: 3. 1. 2. A medtronic representative went to the site to test the equipment. The biopsy needle was unable to track. No hardware parts were replaced. Other biopsy needles were able to track successfully. The system then passed checkout and the system functioning as intended. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding a navigation system used during a cranial biopsy procedure. It was reported that the site was having difficulty tracking a biopsy needle in a case on thursday. The clinical specialist tried unlocking and locking the trajectory multiple times. The navigus probe was tracking as intended. They verified the needle was added as a tool card and they were in a biopsy procedure. The metric when lining up with the trajectory was around 1. 3. The surgeon continued without navigating the needle. The field team and surgeon believe it to be something wrong with the needle it self. Facility is requesting a replacement needle. One of the spheres appeared to be "off. " 5-10 minute delay. No patient impact was correlated with this event.
 
Manufacturer Narrative
A software analysis was initiated. However, the software evaluation found that a probable cause was unable to be determined. If information is provided in the future, a supplemental report will be issued.
 
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Brand NameCART 9733856 S7 STAFF ASSEMBLED 110V
Type of DeviceINSTRUMENT, STEREOTAXIC
Manufacturer (Section D)
MEDTRONIC NAVIGATION, INC
826 coal creek circle
louisville CO 80027
Manufacturer (Section G)
MEDTRONIC NAVIGATION, INC
826 coal creek circle
louisville CO 80027
Manufacturer Contact
stacy ruemping
7000 central avenue ne rcw215
minneapolis, MN 55432
7635260594
MDR Report Key9956995
MDR Text Key187524272
Report Number1723170-2020-01216
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K050438
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/02/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/14/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9733856
Device Catalogue Number9733856
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/13/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/01/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/13/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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