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

Model Number	ILS-0450-KT
Medical Device Problem Codes	Material Fragmentation (1261); Unstable (1667)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
However, the reported behavior is consistent with a known issue in which an internal corrective action was initiated.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during procedure, the wiring started to come lose and fall off ewc.During forcep biopsies it became apparent that wiring was unraveling from the distal tip of the ewc and coming off on the forceps.The surgeon removed ewc and could see wiring unraveling from distal tip.The physician was able to complete the enb portion of the case.There was no patient injury.
Additional Manufacturer Narrative
Evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted that the unit had a catheter lining that had exposed fibers and delaminated ewc liner.It was reported that there was string-like fiber present that appeared to be from the extended working channel, and the procedure kit had a loose component.The reported issues were confirmed.The most likely cause could not be established from the information available.This issue can occur if scratches were made on the extended working channel ptfe liner causing string like fibers.Internal process improvements have been initiated to mitigate this issue.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
• Common Device Name: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): COVIDIEN LP - SUPERDIMENSION INC; 161 cheshire lane, suite 100; plymouth MN 55441
• MDR Report Key: 10756457
• Report Number: 3004962788-2020-00065
• Device Sequence Number: 19097992
• Product Code: JAK
• UDI-Device Identifier: 10884521723832
• UDI-Public: 10884521723832
• 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: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2021

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 Expiration Date: 03/29/2021
• Device Model Number: ILS-0450-KT
• Device Catalogue Number: ILS-0450-KT
• Device Lot Number: 514897
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2020
• Initial Date Received by Manufacturer: 09/30/2020
• Supplement Date Received by Manufacturer: 12/18/2020
• Initial Report FDA Received Date: 10/29/2020
• Supplement Report FDA Received Date: 01/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Weight: 59