MAUDE Adverse Event Report: ILLUMISITE; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Model Number ILS-0900-KT

Device Problems Device Displays Incorrect Message (2591); Application Program Problem (2880)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/15/2021

Event Type  Injury  

Manufacturer Narrative

Out of an abundance of caution, superdimension is filing this mdr due to the additional risk associated with multiple exposures to general anesthesia.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during the procedure, after the first brushing, the error message "navigation catheter is out of sensing volume." appeared.The patient was overweight and wide.Initially had issues getting the sensors to stay in the volume during set up so the sensors were moved more anterior.The legion was located in the left upper lung (lul).The case was not completed and not completed by other means.The patient was under general anesthesia.

Manufacturer Narrative

Additional information: d9, g1 (mfr contact first name, last name, street 1, mfr city, region, postal code, email, phone number, g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.A video was also provided.Visual inspection noted the unit had an internal short.Functionally, the lg length measured at 1046mm and the sewc length measured at 1070mm which both meet length specifications.The locatable guide was tested for continuity using a multimeter and passed.A multimeter was connected to the sewc and the readings were 151.2 ohms.Further functional testing was performed and revealed that the sewc failed continuity testing due to a short to the braid.The complaint was confirmed due to a short to the braid.A dhr review on the sewc (lot#: 515932), lg (lot#: 516169) and procedure kit (lot#: 516186) indicates that these devices were released meeting all quality specifications as manufactured.It was reported that the patient procedure was cancelled or aborted due to a system issue.Also, the locatable guide showed outside of the magnetic volume.The reported issues were confirmed.The most likely cause could not be established from the information available.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 is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.

• Brand Name: ILLUMISITE
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• MDR Report Key: 11613234
• MDR Text Key: 243743816
• Report Number: 3004962788-2021-00029
• Device Sequence Number: 1
• Product Code: JAK
• UDI-Device Identifier: 10884521723825
• UDI-Public: 10884521723825
• Combination Product (y/n): N
• PMA/PMN Number: K191394
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/10/2021
• Device Model Number: ILS-0900-KT
• Device Catalogue Number: ILS-0900-KT
• Device Lot Number: 516186
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2021
• Date Manufacturer Received: 05/19/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/10/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other