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Model Number 9732703 |
Device Problem
Defective Component (2292)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/20/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Patient information was unavailable from the site.A medtronic representative went to the site to test the equipment.Testing revealed that the camera for integration system was replaced.Additionally, the breakout box was found to have an error message related to the mrrf of the system.The footswitch and breakout box were subsequently replaced.Additionally, the software application software was reloaded onto the system and the ssd was replaced to restore functionality.The system then passed a system checkout and was found to be fully functional.The camera for the system was returned to the manufacturer for evaluation.Testing found that the camera could not track instrumentation.The hardware investigation found that the reported event was related to a hardware issue.This issue was documented in a medtronic navigation hardware anomaly tracking database.Other relevant device(s) are: product id: 9731874, serial/lot #: (b)(4), udi#: (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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Medtronic received information regarding an imaging system.It was reported that during a cranial resection procedure the camera was not tracking the instruments.They tried rebooting the system several times with no resolution.Imaging was discontinued for the case.There was a delay of less than one hour due to the issue.There was no reported impact on patient outcome.
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Manufacturer Narrative
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The spring arm assembly was returned to the manufacture for evaluation.After functional testing and visual/physical examination, the reported issue was not confirmed.The returned spring arm was very battered with nicks all along the side of the arm.Otherwise, the cable running through the arm passed a continuity test with no opens or shorts detected.No problem found.The internal cable was returned to the manufacture for evaluation.After functional testing and visual/physical examination the reported issue was not confirmed.The returned cable had no apparent physical damaged and passed a functional test with no issues.No problem found.The break out box was returned to the manufacture for evaluation.After functional testing and visual/physical examination the reported issue was not confirmed.The returned break out box was found to be fully functional when connected to a known good system returning green status for all instrument ports and a functional foot switch.No problem found.The foot switch cable was returned to the manufacture for evaluation.After functional testing and visual/physical examination, the reported issue was not confirmed.The returned foot switch was found to be fully functional when connected to a known good system.No problem found.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Additional information was received stating as reported in troubleshooting was done and they reinstalled on the system and system cleaning up.It was founded that the issue was caused from the sdd on the system.
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Manufacturer Narrative
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H2) additional information was added to the event description.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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