STEALTHSTATION¿ S8 SYSTEM
Report
- Report Number
- 1723170-2025-02336
- Event Type
- Malfunction
- Date Received
- June 16, 2025
- Date of Event
- June 4, 2025
- Report Date
- July 3, 2025
- Manufacturer
- MEDTRONIC NAVIGATION, INC
- Product Code
- HAW
- UDI-DI
- 00643169722187
- PMA / PMN Number
- K162309
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- 003
Narratives
CONTINUATION OF D10: SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 9735821R. H3, H6: A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. AFTER CAMERA REPLACEMENT, THE SYSTEM FUNCTIONED AS INTENDED. CODES B01, C08 AND D02 ARE APPLICABLE TO THIS ANALYSIS. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
A1 AND B5 ADDITIONAL INFORMATION H3, H6: THE CAMERA, LOT NUMBER: P901393, WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE RETURNED CAMERA HAD SCRATCHES ON THE HOU SING AND LENSES. A CHECK OF THE EVENT LOG SHOWED INTERMITTENT FIRMWARE INCOMPATIBILITY AND INTERMITTENT ILLUMINATOR CURRENT LOW. THERE WAS A BATTERY VOLTAGE LOW MESSAGE ALONG WITH BUMP DETECTED AND STORAGE TEMPERATURE EXCEEDED. THE POWER SUPPLY UNIT (PSU) FAILED AN ACCURACY TEST (AAK) AT .663MM WITH A PASSING THRESHOLD OF .250MM. LINE SEPARATION WAS DETECTED DURING TESTING. THE REPORTED EVENT COULD BE DUPLICATED BY MEDTRONIC PERSONNEL. CODE C02 IS ADDITIONALLY APPLICABLE TO THIS ANALYSIS. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED. IT WAS REPORTED THAT THERE WAS A LOCALIZER FAULTED MESSAGE WHILE SETTING UP FOR AN UNKNOWN PROCEDURE. THERE WAS AN AMBER LED PRESENT ON THE POSITIONING SENSOR UNIT (PSU). THE SITE DID NOT HAVE ANOTHER NAVIGATION SYSTEM TO USE. THE ISSUE CAUSED A SURGICAL DELAY OF ONE HOUR OR LONGER. CONFLICTING INFORMATION WAS REPORTED. IT WAS REPORTED THAT THE PATIENT PRESENCE WAS UNKNOWN, BUT LATER NOTED THAT THERE WAS PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS RECEIVED. A MANUFACTURER REPRESENTATIVE (REP) REPORTED THAT LOCALIZER FAULTED WAS DISPLAYED. THE REP REBOOTED THE SYSTEM AND IT DID NOT GO AWAY. THE NETWORK DEVICE INTERFACE (NDI) TOOLBOX STATED THAT THE YELLOW BOX WAS HIGHLIGHTED ON BUMP AND INTERNAL TEMPERATURE - INDICATING THAT THE BATTERY HAD MET ITS LIFESPAN.
ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THIS ISSUE OCCURRED BEFORE A PROCEDURE WITH NO PATIENT PRESENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1503511 | STEALTHSTATION¿ S8 SYSTEM | NEUROLOGICAL STEREOTAXIC INSTRUMENT | HAW | MEDTRONIC NAVIGATION, INC | 9735665 | 00643169722187 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | "SEE H11...." |