MEDTRONIC NAVIGATION, INC (LITTLETON) O-ARM 1000 IMAGING SYSTEM 3RD EDITION; IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, M
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Model Number BI70000028120 |
Device Problems
Positioning Problem (3009); Application Program Freezes, Becomes Nonfunctional (4031)
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Patient Problem
Unspecified Tissue Injury (4559)
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Event Date 06/29/2023 |
Event Type
Injury
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Event Description
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Medtronic received information regarding an imaging system used in a sacroiliac and thoracolumbar procedure.It was reported that the site was unable to expose along with multiple other issues.Before the case, they had difficulty getting the system to complete it's bootup procedure, but after multiple reboots it powered on.Once powered on they moved it to around the patient and then were unable to take a 3d scan.They then were unable to remove the system from around the patient, but after multiple reboots they were then able to get the system removed and aborted the case.This included that imaging, navigation, and surgery were aborted.The surgery was rescheduled.There was less than 1 hour delay in the surgery.
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Manufacturer Narrative
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H3.The system was serviced in the field, and the reported symptoms was unable to be reproduced.However, it was discovered that the machine would not dock during testing as the x-stage was getting jammed when extended.The x-stage cover was removed and invalidated home.The x-stage cover was re-installed, and system checkout completed.The imaging system was operational.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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Section d information references the main component of the system and other applicable components are: kit svc bi71000483 o1000 x-stage cover.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.
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