ILLUMISITE
Report
- Report Number
- 3004962788-2024-00112
- Event Type
- Malfunction
- Date Received
- October 2, 2024
- Date of Event
- September 24, 2024
- Report Date
- March 7, 2025
- Manufacturer
- COVIDIEN LP - SUPERDIMENSION INC
- Product Code
- JAK
- UDI-DI
- 10884521723825
- PMA / PMN Number
- K191394
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
ADDITIONAL INFORMATION: D9, G3, H3, H6 H3 EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. THE DEVICE WAS AVAILABLE FOR EVALUATION. VISUAL INSPECTION NOTED THAT THE EWC WAS KINKED 180MM FROM THE END OF THE HANDLE. FUNCTIONALLY, THE INNER DIAMETER OF THE EWC WAS CHECKED WITH A BALL MANDREL, BUT IT WAS UNABLE TO PASS THROUGH THE KINK. RESISTANCE OF THE EWC WAS STILL NORMAL. THE LG LENGTH WAS MEASURED USING A CALIBRATED RULER AND WAS FOUND TO BE WITHIN SPECIFICATION. THE LG CONTINUITY WAS CHECKED WITH A BREAKOUT BOARD AND THE RESULTS WERE ACCEPTABLE. IT WAS REPORTED THAT THE LOCATABLE GUIDE WAS NOT DETECTED, THE EXTENDED WORKING CHANNEL WAS MOVING DURING SWEEP AND THERE WAS AN ERROR OF OUT OF SENSING VOLUME. THE REPORTED ISSUES COULD NOT BE CONFIRMED. THE MOST LIKELY CAUSE COULD NOT BE ESTABLISHED FROM THE INFORMATION AVAILABLE. THE EVALUATION DETECTED AN UNREPORTED CONDITION: THE INNER DIAMETER OF THE EWC WAS CHECKED WITH A BALL MANDREL, BUT IT WAS UNABLE TO PASS THROUGH THE KINK. THE PRODUCT ANALYSIS NOTED EVIDENCE THAT THE DEVICE WAS NOT USED AS INTENDED. INTERNAL PROCESS IMPROVEMENTS HAVE BEEN INITIATED TO MITIGATE THIS ISSUE. THE MANUFACTURING RECORDS FOR EACH DEVICE ARE THOROUGHLY REVIEWED PRIOR TO RELEASE TO ENSURE THAT IT MEETS ALL MEDTRONIC QUALITY SPECIFICATIONS. A SECONDARY REVIEW OF THE DEVICE HISTORY RECORDS FOUND NO POTENTIALLY CONTRIBUTING FACTORS. 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.
D10. CONCOMITANT PRODUCT: ILS-0900-KT, ILS-0900-KT PROCEDURE KIT ILLUMISITE 90 (LOT#529195) 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. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE LOCATABLE GUIDE WAS NOT DETECTED OR RECOGNIZED. THE SYSTEM ALSO DETECTED THAT THE EXTENDED WORKING CHANNEL WAS MOVING DURING SWEEP. WHEN THE SURGEON BEGAN TO SAMPLE, A NEW CATHETER WAS USED, BUT THERE WAS AN ERROR OF OUT OF SENSING VOLUME, CATHETER FLICKERING ON SCREEN, AND OTHER ERRORS. THE PHYSICIAN WAS ABLE TO COMPLETE THE ELECTROMAGNETIC NAVIGATIONAL BRONCHOSCOPY (ENB) PORTION OF THE CASE. THERE WAS NO PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1091594 | ILLUMISITE | SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED | JAK | COVIDIEN LP - SUPERDIMENSION INC | ILS-0900-KT | 528991 | 10884521723825 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | SEE H11. |