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

Model Number	ILS-1800-KT
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Codes	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the procedure for a suspicious lung nodule, the inner layer of the extended working channel was abraded when the biopsy forceps were inserted, resulting in device fragments becoming loose in the patient.The intervention time was prolonged but not for more than 30 minutes as the foreign bodies had to be removed from the patient piece by piece.The biopsy was ultimately performed without the use of the extended working channel and navigation at the end of the procedure.All device fragments were removed from the patient.There was no patient injury.
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
Correction: b2 (intervention required), b5, h1, h6 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
It was reported that during the procedure for a suspicious lung nodule, the inner layer of the extended working channel was abraded when the biopsy forceps were inserted, resulting in device fragments becoming loose in the patient.The intervention time was prolonged but not for more than 30 minutes as the foreign bodies had to be removed from the patient piece by piece.The biopsy was ultimately performed without the use of the extended working channel and navigation at the end of the procedure.All device fragments were removed from the patient.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6 correction: h5, h8 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted string like fibers.The string like fiber was determined to be from scraping the inner liner.Functional testing noted that both the lg and ewc lengths, measured using a calibrated ruler, were within specification.The ewc was also checked with a ball mandrel and passed without resistance.Upon cutting open the ewc for internal inspection, scrapes and gouges were observed.It was reported that a string-like fiber was present.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.The instructions included with this device provide the following guidance: with the jaws closed, insert the distal tip of the device into the extended working channel.Advance the device using short, 2cm strokes.When the biopsy operation is complete, ensure that the jaws remain closed and slowly withdraw the forceps from the extended working channel.If the jaws will not close completely, do not use force to pull the jaws into the extended working channel.Remove the endoscope and the extended working channel with the forceps still in place.Then manually close the jaws and remove the forceps and extended working channel from the endoscope.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: 23318684
• Report Number: 3004962788-2025-00119
• Device Sequence Number: 4967390
• Product Code: JAK
• UDI-Device Identifier: 10884521723818
• UDI-Public: (01)10884521723818(17)280406(10)531015
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/08/2025

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-1800-KT
• Device Catalogue Number: ILS-1800-KT
• Device Lot Number: 531015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2025
• Supplement Date Received by Manufacturer: 10/21/2025; 12/05/2025
• Initial Report FDA Received Date: 10/16/2025
• Supplement Report FDA Received Date: 10/22/2025; 12/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/07/2025
• 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: 59 YR
• Patient Sex: Female