Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: 9735825, serial/lot #: unknown; product id: 9735824, serial/lot #: unknown.H3: a medtronic representative went to the site to test the equipment.Testing revealed that the electromagnetic (em) interface box and em controller were replaced.It was indicated by the representative that the system was not ready for clinical use due to modifications that have been done to the system by the site.H6: fdm b01, fdr c13, fdc d02 are applicable to the system checkout.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 have not 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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Medtronic received information regarding a navigation device being used outside of a procedure.It was reported that during the start of the case, the connectors/pins were discovered to be damaged on the breakout box (bob) cable.It was noted that the mating connector side could have been damaged as well.The site had to swap out the navigation system due to the discovered issue.From the images provided by the site, there were exposed wires and the pins were no longer connected to the port head.The bob would not work on the system either.The bob and emitter were grey, and there were no lights on the bob."controller faulted" is the message that appeared on the camera diagnostics. there was no known patient involvement.The issue occurred preoperatively during setup for a functional endoscopic sinus surgery (fess) before the patient was in the room.
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