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

Model Number	ILS-1000-CS
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fever (1858); Fistula (1862); Pneumothorax (2012)
Date of Event	06/26/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the literature source of study performed between march 2019 to february 2024, a retrospective study analyzed the hybrid treatment of multifocal lung malignancy by concomitant transbronchial microwave ablation with same-session lung resection and post-lung resection ablation with concomitant video-assisted thoracoscopic lung resection.A total of 92 patients were included in the study.There were 103 procedures performed and 162 lung nodules treated 142 lung nodules were ablated and 20 lung nodules were resected.6 patients had complications 1) persisted fever, (2) airway bleeding, (2) pneumothorax and (1) bronchopleural fistula.Oral antibiotics were given, chest tube drainage was done and endobronchial valve placement on.Re-admission was required.Hybrid treatment of multifocal lung malignancy by concomitant transbronchial microwave ablation with same-session lung resection and post-lung resection ablation.  dr.Calvin ng, 2025, interdisciplinary cardiovascular and thoracic surgery.
Additional Manufacturer Narrative
D10 concomitant products: sdatsw01, sdatsw01 access tool straight wire (lot#:unknown), aas00161-20, aas00161-20 us superd navigation system (serial#:unknown), unk needle, unknown biopsy needle (lot#:unknown), unk ewc, unknown extended working channel (lot#:unknown), unk emprint ant, unknown emprint antenna (lot#:unknown), unk emprint ant, unknown emprint antenna (lot#:unknown), ils-1000-cs, ils-1000-cs illumisite console (serial#:unknown), sdatsw01, sdatsw01 access tool straight wire (lot#:unknown), aas00161-20, aas00161-20 us superd navigation system (serial#:unknown), unk needle, unknown biopsy needle (lot#:unknown), unk ewc, unknown extended working channel (lot#:unknown) aliss t.C.Chang, joyce w.Y.Chan, ivan c.H.Siu, rainbow w.H.Lau, cheuk man chu, tony s.K.Mok, and calvin s.H.Ng."hybrid treatment of multifocal lung malignancy by concomitant transbronchial microwave ablation with same-session lung resection and post-lung resection ablation." interdisciplinary cardiovascular and thoracic surgery 2025, 40(7), ivaf152.Https://doi.Org/10.1093/icvts/ivaf152 advance access publication 27 june 2025 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: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 22926527
• Report Number: 3004962788-2025-00100
• Device Sequence Number: 9156727
• Product Code: JAK
• UDI-Device Identifier: 10884521723634
• UDI-Public: 10884521723634
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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: Foreign,Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/29/2025

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?: No
• 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: 08/06/2025
• Initial Report FDA Received Date: 08/29/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Unknown