MEDTRONIC NAVIGATION, INC (LITTLETON) O-ARM 1000 IMAGING SYSTEM; IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, M
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Model Number BI70000027100 |
Device Problem
Poor Quality Image (1408)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/26/2024 |
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: bi71000734; product id: bi70000053, h6: multiple annex g codes were coded for this event.G0201402 corresponds to concomitant product panel assy bi70000053 rear cab bre akout.G02017 corresponds to concomitant product kit svc bi71000734 plr iport ethr.H3, h6: no products have been received by the manufacturer for analysis.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 sacroiliac and thoracolumbar procedure.It was reported that the coronal and sagittal 3d images of the imaging system were blurred.The site transferred the images to the navigation system, and continued operation of the imaging system.This occurred intraoperatively, and there was no surgical delay.There was no reported impact to patient outcome.
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Manufacturer Narrative
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H2) continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: bi71000734, serial/lot #: 1338417 rev.4, product id: bi70000053, serial/lot #: (b)(6) rev.7, product id: bi40000019r, serial/lot #: (b)(6) rev.4.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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Event Description
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2024-mar-7 ared (rep, for): no new information.
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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: bi40000019r, serial/lot #: unknown.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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Manufacturer Narrative
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H3, h6: the system was serviced in the field and hardware parts were replaced.B01, c13, and d02 are applicable.Product bi70000053, lot number: 449728 rev.7 was received by the manufacturer for analysis.Continuity test passed.No physical damage.No failure was found.B01, c19, and d14 are applicable.Product bi71000734, lot number: 1338417 rev.4 was received by the manufacturer for analysis.The product was installed in a test system and no failure was found.B01, c19, and d14 are applicable.Product bi40000019r, lot number: cm17495 rev.4 was received by the manufacturer for analysis.The product was installed in a test system and no failure was found.B01, c19, and d14 are applicable.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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