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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC CART 9734056 S7 STAFF SHRT 100-120V INTL NEUROLOGICAL STEREOTAXIC INSTRUMENT

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MEDTRONIC NAVIGATION, INC CART 9734056 S7 STAFF SHRT 100-120V INTL NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 9734056
Device Problem Display or Visual Feedback Problem (1184)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/11/2021
Event Type  malfunction  
Event Description
Medtronic received information regarding a navigation device being used for a tumorectomy procedure. It was reported that the color of the surgeon monitor screen had changed, and instead it was displayed on the ceiling monitor with an external output and the operation was completed. During verification, there was reproducibility. The surgeon monitor external cable was replaced and the screen was confirmed to be normal. No impact on patient outcome. There was no delay.
 
Manufacturer Narrative
A medtronic representative went to the site to test the equipment. Testing revealed that the cable was replaced. The imaging system then passed the system checkout and was found to be fully functional. Analysis found on cable- analysis determined there a continuity test revealed an open from pin 12 of the fischer connector to pin 9 of the hd26 connector. Continuation of concomitant medical products: other relevant device(s) are: product id: 9733571, sn/lot# (b)(4). If information is provided in the future, a supplemental report will be issued.
 
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Brand NameCART 9734056 S7 STAFF SHRT 100-120V INTL
Type of DeviceNEUROLOGICAL STEREOTAXIC INSTRUMENT
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
glen belmer
7000 central avenue ne rcw215
minneapolis, MN 55432
6122713209
MDR Report Key12990366
MDR Text Key290270968
Report Number1723170-2021-02879
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K050438
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/27/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/13/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model Number9734056
Device Catalogue Number9734056
Was Device Available for Evaluation? No
Date Returned to Manufacturer11/22/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/25/2022
Was Device Evaluated by Manufacturer? Yes
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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