MEDTRONIC XOMED INC. IPC® HANDPIECE - INDIGO¿ DRILL; DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE
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Model Number 1845000 |
Device Problem
Overheating of Device (1437)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/04/2024 |
Event Type
malfunction
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Manufacturer Narrative
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H3: analysis results were not available as of the date of this report.A supplemental report will be submitted when analysis is complete.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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It was reported that drill had overheating issue.No patient involvement.
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Manufacturer Narrative
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H3: product analysis could not confirm the customer's complaint.Pre-repair temperature check performed at 60k resulted into 80f at the t1 and 82f at the t2 after 1 minute.No anomalies have been found.H6:previous codes b21,c21 and d16 are no longer valid.Product analysis received shows that there is no information to reasonably suggest that the device in this report may have caused or contributed to a death or serious injury or that the device in this report has malfunctioned.Therefore, this event did not and does not meet the reporting requirements stipulated in 21 cfr 803." 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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