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 02/28/2024 |
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 follow-up 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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A health care professional reported that, during intra-op indigo handpiece was overheating and froze up.There was no patient involved in the event.
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Manufacturer Narrative
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H3: product analysis found that, the customer's complaint has been confirmed.The motor and collet bearings were corroded.The pre-repair temperature in fahrenheit at 1 min of testing handpiece temperature were t1-171 and t2-195.H6: codes are updated.Previously applied fdm b21, fdr c21, fdc d16 and img g04063 codes no longer applicable.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant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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