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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC STEALTHSTATION¿ S8 SYSTEM; EAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT

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MEDTRONIC NAVIGATION, INC STEALTHSTATION¿ S8 SYSTEM; EAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 9735669
Device Problem Imprecision (1307)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/02/2023
Event Type  malfunction  
Manufacturer Narrative
Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: 9735736, serial/lot #: 2.0.1, ubd:- , udi#:- h3, h6: no products have been returned to medtronic for analysis.Codes b17, c20, and d15 are applicable.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding a navigation device being used during a functional endoscopic sinus surgery (fess) procedure.It was reported that the site experienced an inaccuracy of 5.8mm when using the straight suction immediately after registering and navigating into the sinus.It was also noted that it was off between the eyebrows externally as well, but did not specify a magnitude.The site decided to re-register the patient and still noticed an inaccuracy of 2.5mm and 2.7mm when using the straight suction.When using the microdebrider (4.3mm quadcut), there was a small inaccuracy but it was less than 2mm.No patient impact.
 
Manufacturer Narrative
H3,h6: a software analysis was initiated to determine the probable cause of the reported behavior.Analysis found that there was insufficient information to determine if the issue came from a software anomaly.The logs were reviewed and the logs captured multiple coil noise messages for the tools.This might have caused the accuracy issue.The archive were also reviewed and the archive had 1-ct exams with spacing and thickness 0.25 mm and 481 slices.The registration accuracy was 1.2 mm for the exam with less green zone of accuracy and the registration pattern was not good as most of the points were under the skin and overlapping each other and most of the tracing was done on the nose only.The 3d model was also not good, as it was cropped from top, bottom and back side, the scans should have been included from the top of the mandible to the top of the head to allow for more anatomy to be registered on.Codes b01,c19,d15 are applicable and previously reported.Correction: section d2 updated.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received.There was a 10 minute delay in surgery.
 
Manufacturer Narrative
B5: additional information added.H3, h6: the system was serviced in the field and no failure was found.B01, c19, and d14 are applicable.H3, h6: software data was received for analysis.However, analysis hasn't been completed.B21, c21, and d16 are applicable.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
 
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Brand Name
STEALTHSTATION¿ S8 SYSTEM
Type of Device
EAR, NOSE, AND THROAT 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 Key17458410
MDR Text Key320513834
Report Number1723170-2023-01389
Device Sequence Number1
Product Code PGW
UDI-Device Identifier00643169838918
UDI-Public00643169838918
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K162309
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 09/08/2023
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
Device Operator Health Professional
Device Model Number9735669
Device Catalogue Number9735669
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/02/2023
Initial Date FDA Received08/04/2023
Supplement Dates Manufacturer Received08/04/2023
09/06/2023
Supplement Dates FDA Received08/23/2023
09/08/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/20/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Treatment
SEE H10
Patient Age64 YR
Patient SexFemale
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