MEDTRONIC XOMED INC. TRICUT® STRAIGHT SHAFT 4MM 13CM LONG M4 ROTATABLE WITH EM TRACKING; BUR, EAR, NOSE AND THROAT
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Model Number 1884080EM |
Device Problems
Break (1069); Overheating of Device (1437)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/28/2023 |
Event Type
malfunction
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Event Description
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It was reported that during the procedure, in the first five minutes of the case, the tricut blade plastic meted off on the exiting sinus.The blade was hot to touch at 30000 rpm.The blade was broken while being used on the patient.There was 1-2 minute delay in the procedure.The blade was broken. the procedure was completed with a backup product.There was no patient impact.
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Manufacturer Narrative
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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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H3 : it was found in the analysis report that visually, the inner shaft was broken 0.60 inches from the distal end of the inner hub when returned.A portion of the outer hub 0.76 inches in length was broken off from the blade assembly and was deformed and portions of the tracker hub wire were cut.There was contamination on the outside diameter of the outer tube and inner hub, and inside diameter of the inner tip.Functional testing could not be performed due to the broken state of the device.Per the inner and outer packaging labels, the device shall oscillate up to 7500rpm.In the returned condition, there was an out of specification condition that was related to the complaint (due to physical damage).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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Additional information was received that the blade did not detach inside the patient.The product was melted on the exiting sinus while inside the patient and was quickly removed.
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Search Alerts/Recalls
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