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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 INSTRUMENT, STEREOTAXIC

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MEDTRONIC NAVIGATION, INC CART 9734056 S7 STAFF SHRT 100-120V INTL INSTRUMENT, STEREOTAXIC Back to Search Results
Model Number 9734056
Device Problems Audible Prompt/Feedback Problem (4020); Application Program Freezes, Becomes Nonfunctional (4031)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/09/2020
Event Type  malfunction  
Manufacturer Narrative
The system was serviced in the field and failed software and instrument tests due to the instrument geometry and audio (sound and volume). There was a geometry error of error 5mm. Hardware parts were replaced and the failure was resolved. It was later noted that reinstalling the application resolved the issue. 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 functional endoscopic sinus surgery (fess). It was reported that there was no sound during registration and the screen remained frozen. The product was used by rebooting the device. No sound was heard after rebooting. There was no delay and no impact to the patient.
 
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Brand NameCART 9734056 S7 STAFF SHRT 100-120V INTL
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
tricha miles
7000 central avenue ne rcw215
minneapolis, MN 55432
7635140379
MDR Report Key10740972
MDR Text Key213239078
Report Number1723170-2020-02806
Device Sequence Number1
Product Code PGW
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 company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 01/29/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/27/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9734056
Device Catalogue Number9734056
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/28/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/27/2012
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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