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 Network Problem (2879); Application Program Problem (2880)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/25/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the reporter, during an electromagnetic navigation bronchoscopy (enb) procedure, the software was showing that they were on the lower lobe, while fluoroscopic imaging showed them in the upper lobe.It was also reported that the device was showing as o utside of the sensor sensing volume.
Additional Manufacturer Narrative
D10 concomitant product: ils-1800-kt, ils-1800-kt procedure kit illumisite 180 (lot#529145) out of an abundance of caution, superdimension is filing this mdr due to the additional risk associated with multiple exposures to general anesthesia.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.
Event or Problem Description
According to the reporter, during an electromagnetic navigation bronchoscopy (enb) procedure, after local registration, it was discovered that orange cable had been jarred loose at some point due to a sticking drawer on the front of the tower.The software was showing that they were on the lower lobe while fluoroscopic imaging showed them in the upper lobe.It was also reported that the device was showing as outside of the sensor sensing volume.The procedure was cancelled due to the issue and was not completed by other means.The procedure would be rescheduled.The patient was under general anesthesia.
Additional Manufacturer Narrative
Additional information: b1, b2, b5, b6, g3, h1, h3, h6 (fdd) new information has been received pertaining to the event.This event has been reassessed and the reportability has been determined to be a serious injury.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: a1, a2, a3a, a4, b5, g3, h6 (fdr).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.
Event or Problem Description
According to the reporter, during a electromagnetic navigation bronchoscopy (enb) procedure, after local registration it was discovered that orange cable has been jarred loose at some point due to a sticking drawer on the front of the tower, the software is showing that they were on the lower lobe, while fluoroscopic imaging showed them in the upper lobe.It was also reported that the device was showing as outside of the sensor sensing volume.The original cord is still in use and was plugged back into the continues guidance system (cgs).The procedure was cancelled due to the issue and was not completed by other means.The procedure was reschedule.The patient was under general anesthesia.
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 electronic device-use logs were also provided.The evaluation found no potentially contributing factors, and the sample met all related specifications.It was reported that the device was outside of magnetic volume, and there was a system inaccuracy.The reported issues 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: 20651947
• Report Number: 3004962788-2024-00124
• Device Sequence Number: 6641083
• Product Code: JAK
• UDI-Device Identifier: 10884521723634
• UDI-Public: 10884521723634
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/18/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2024
• Supplement Date Received by Manufacturer: 11/05/2024; 11/21/2024; 02/13/2025
• Initial Report FDA Received Date: 11/11/2024
• Supplement Report FDA Received Date: 11/13/2024; 12/02/2024; 02/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/02/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PLEASE SEE NOTE ON H11
• Outcome Attributed to Adverse Event: Other
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 81 KG