ILLUMISITE
Report
- Report Number
- 3004962788-2024-00151
- Event Type
- Malfunction
- Date Received
- December 27, 2024
- Date of Event
- December 5, 2024
- Report Date
- March 14, 2025
- Manufacturer
- COVIDIEN LP - SUPERDIMENSION INC
- Product Code
- JAK
- PMA / PMN Number
- K191394
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- EZ
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
ADDITIONAL INFORMATION: G3, H3, H6 H3 EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. THE DEVICE WAS AVAILABLE FOR EVALUATION. THE EVALUATION FOUND REGISTRATIONS ERRORS IN THE LOGS, BUT THE SYSTEM WAS WORKING PROPERLY. IT WAS REPORTED THAT THERE WAS A REGISTRATION ISSUE. THE REPORTED ISSUE WAS CONFIRMED. THE MOST LIKELY CAUSE COULD NOT BE ESTABLISHED FROM THE INFORMATION AVAILABLE. THE MANUFACTURING RECORDS FOR EACH DEVICE ARE THOROUGHLY REVIEWED PRIOR TO RELEASE TO ENSURE THAT IT MEETS ALL MEDTRONIC QUALITY SPECIFICATIONS. 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.
ADDITIONAL INFORMATION: B5, G3, H6 (FDR - C100205). 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.
ADDITIONAL INFORMATION: B3, B5, G3, H3. CORRECTION: E1 (FIRST NAME, LAST NAME, PHONE NUMBER), E3, E4 (EMAIL). 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 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.
IT WAS REPORTED THAT DURING THE PROCEDURE, IN THE AUTOMATIC NAVIGATION PROCESS OF THE PRODUCT NONE OF THE LANDMARKS COULD BE REGISTERED EXCEPT FOR THE RIGHT LOWER LOBE, INDICATING A REGISTRATION ISSUE. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE ISSUE. UPON SERVICING, THE UNIT WAS CLEANED. PREVENTATIVE MAINTENANCE DONE AND PASSED. THE UNIT CAN BE FULLY USED.
IT WAS REPORTED THAT DURING THE PROCEDURE, IN THE AUTOMATIC NAVIGATION PROCESS OF THE PRODUCT NONE OF THE LANDMARKS COULD BE REGISTERED EXCEPT FOR THE RIGHT LOWER LOBE, INDICATING A REGISTRATION ISSUE. THE PHYSICIAN WAS ABLE TO COMPLETE THE SUPERDIMENSION PORTION OF THE CASE. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE ISSUE. UPON SERVICING, THE UNIT WAS CLEANED. PREVENTATIVE MAINTENANCE DONE AND PASSED. THE UNIT CAN BE FULLY USED.
IT WAS REPORTED THAT DURING THE PROCEDURE, IN THE AUTOMATIC NAVIGATION PROCESS OF THE PRODUCT, NONE OF THE LANDMARKS COULD BE REGISTERED EXCEPT FOR THE RIGHT LOWER LOBE, INDICATING A REGISTRATION ISSUE. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2496349 | ILLUMISITE | SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED | JAK | COVIDIEN LP - SUPERDIMENSION INC | ILS-1000-CS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |