MAUDE Adverse Event Report: COVIDIEN LP - SUPERDIMENSION INC ILLUMISITE; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Model Number	ILS-1000-CS
Medical Device Problem Codes	Device Displays Incorrect Message (2591); Application Program Problem (2880); Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure involving the superdimension system, an invalid navigation catheter movement error occurred.Initially, the patient sensor triplet (pst) was not visible in the software, prompting the cable to be unplugged and reconnected.The pst was then seen, but remained out of the sensing volume, necessitating multiple adjustments to the patient's position.The physician was unable to complete the superdimension portion of the case.The procedure was ultimately completed using endobronchial ultrasound (ebus) while the patient was under anesthesia.No patient complications have been reported as a result of this event.Upon servicing, performed accuracy checkout procedure and flouro checkout procedure.Accuracy checkout and flouro procedure passed.
Additional Manufacturer Narrative
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 Manufacturer Narrative
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 no potentially contributing factors, and the sample met all related specifications.It was reported that there was an invalid navigation catheter movement error occurred.Initially, the patient sensor triplet (pst) was not visible in the software, prompting the cable to be unplugged and reconnected.The pst was then seen, but remained out of the sensing volume, necessitating multiple adjustments to the patient's position.The reported issue could not be confirmed.The most likely cause could not be identified because no related problem was detected with the device.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.

• Brand Name: ILLUMISITE
• Common Device Name: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): COVIDIEN LP - SUPERDIMENSION INC; 161 cheshire lane, suite 100; plymouth MN 55441
• Manufacturer (Section G): COVIDIEN LP - SUPERDIMENSION INC; 161 cheshire lane, suite 100; plymouth MN 55441
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 21470899
• Report Number: 3004962788-2025-00035
• Device Sequence Number: 18321405
• Product Code: JAK
• UDI-Device Identifier: 10884521723634
• UDI-Public: 10884521723634
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K191394
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2025

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
• Operator of Device: Health Professional
• Device Model Number: ILS-1000-CS
• Device Catalogue Number: ILS-1000-CS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2025
• Supplement Date Received by Manufacturer: 05/08/2025
• Initial Report FDA Received Date: 02/26/2025
• Supplement Report FDA Received Date: 05/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/11/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown