COVIDIEN LP - SUPERDIMENSION INC SUPERDIMENSION INREACH SYSTEM; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
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Model Number AAS00161-12 |
Device Problems
Defective Device (2588); Device Displays Incorrect Message (2591)
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Patient Problem
No Code Available (3191)
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Event Date 08/20/2019 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).If information is provided in the future, a supplemental report will be issued.
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Event Description
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According to the reporter, during the procedure, there was a system error code.The system prompted to check patient sensors after obtaining some samples.All sensors were in place and untouched.The super dimension portion of the case was not completed and was not completed by other means.The patient was under general anesthesia.
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Manufacturer Narrative
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Additional information: g4, h3, h6 h3 evaluation summary: according to procedure recordings video, the physician started automatic registration, achieved 5 check marks, moved to verification and began navigation.After 3 minutes of navigation, ¿a patient sensor has moved¿ message was displayed.Analysis of procedure recordings confirmed a 23 mm movement (over the y axis) of one of the patient sensors.A minute after the message was displayed the sensors were repositioned.The physician did not press ¿done¿.Ten minutes later patient sensors were removed and 22 minutes after that the procedure was ended.No unusual events were observed on the procedure recording video or logs.No software malfunction found.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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Additional information: d4(udi), g3, correction: updated rfr code, h6(fdd code was removed) 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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Manufacturer Narrative
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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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