Model Number BI70002000 |
Device Problems
Mechanical Problem (1384); Failure to Advance (2524); Application Program Freezes, Becomes Nonfunctional (4031)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/03/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: b i71000202, serial/lot: unknown, product id: bi71000203, serial/lot: unknown, product id: bi71000273, serial/lot: unknown, product id: bi71000429, serial/lot: unknown, product id: bi71000144, serial/lot: unknown, and product id: bi71000085, serial/lot: unknown h3, h6) no parts have returned to the manufacturer for analysis.Codes b17, c20, and d15 are applicable.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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Event Description
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Medtronic received information regarding an imaging system being used during a cervical spine procedure.It was reported that imaging system was positioned over the patient and a couple of two-dimensional (2d) images were taken.They went to switch to three-dimensional (3d) mode, and the system went into e-stop mode.The dongle had gotten snapped off and he was able to reset e-stop but the gantry doors would not opened.They had to move the operating room (or) bed to position it so a non-medtronic product could be brought in to continue with the surgery.After the surgery, they took the patient off the bed and disassembled the bed so that the medtronic imaging system could be removed from the or.Medtronic imaging was aborted.There was no impact to patient's outcome and surgical delay was reported as 20-minutes.
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Manufacturer Narrative
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H6) a manufacturer representative went to the site to test the imaging system.Testing revealed that numerous damaged parts were found.The screws were extracted and the door winch, rotor tractor drive, dingus, upper door cap, and cable guides were replaced.Once hardware was replaced, the system performed as intended.Codes b01, c07, and d02 are applicable.H2) continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: bi71000192, serial lot: unknown.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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