MDT POWERED SURGICAL SOLUTIONS MOTOR MR8 ELECTRIC; DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE
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Model Number EM800-R |
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 02/14/2024 |
Event Type
malfunction
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Manufacturer Narrative
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Correction in g2: event occured in united states.Hence corrected the info.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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Repair request initiated for device with the report of overheating.It was reported that there was no patient impact.Repair request escalated to product event due to return in less than 90 days from purchase or repair.
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Manufacturer Narrative
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H3:evaluation determine that the device was tested and the temperature was measured to be 213°f.The rate of temperature rise was above threshold at 245.1°f/sec.The likely cause was identified as worn front and rear bearings.It was also noted that shaft was corroded, the motor ran for 24 seconds before it seized and shut down.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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