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Model Number ILS-0900-KT |
Device Problems
Device Displays Incorrect Message (2591); Application Program Problem (2880)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 05/18/2023 |
Event Type
Injury
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Event Description
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According to the reporter, during a procedure, when trying to navigate to the target, the system kept giving an error message that the catheter was out of sensing volume.The surgeon pulled the patient up higher on the board and positioned the left lower lobe more centered on the board.To raise the patient up a couple of inches, the user tried placing blankets underneath the patient.However, the issue still occurred.A new catheter was used, but the same error message persisted.The physician was not able to complete the case even by other means.The patient was under general anesthesia.The patient was going for the surgery instead of rescheduling.
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Manufacturer Narrative
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Out of an abundance of caution, superdimension is filing this mdr due to the additional risk associated with multiple exposures to general anesthesia.H6 patient codes - e2402 (cancelled case) d10 concomitant product/s: ils-0900-kt ils-0900-kt procedure kit illumisite 90 lot #:525335.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.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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Medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted the ewc had separated from the luer, the sensor wire of the ewc had been severed and the glue port showed the adhesive to be in spec (fully cured with adequate amount).It was reported that the patient procedure was cancelled or aborted due to a system issue and the system displays error message indicating lg or pst was outside 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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