Catalog Number PFSR101209 |
Device Problems
Overheating of Device (1437); Noise, Audible (3273)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/11/2020 |
Event Type
malfunction
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Event Description
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It was reported that during a navio ukr procedure, the ukr drill got very hot and very noisy.They were still able to use the same device to complete the procedure without delays.No other complications were reported.
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Manufacturer Narrative
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H3, h6: the navio drill, part number 101209, s/n (b)(6), used in treatment was not returned for evaluation; thus, a visual and functional evaluation could not be performed, and a relationship between the reported event and the device could not be determined.A review of manufacturing and service records indicate the device met all specifications upon release into distribution.A complaint history review for similar reported/confirmed complaints has identified prior events.Although the reported problem was not confirmed, a factor that may have contributed to the reported symptoms may have been mechanical component failure, as the motor shaft wears over time, causing heat and noise.Although no further containment or corrective action is recommended or required at this time, all complaints are monitored and trended through post market surveillance activities.If the product associated with this event is returned or provided at a future date, this evaluation will be reopened for investigation.
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Manufacturer Narrative
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H3, h6: the navio drill, part number 101209, s/n (b)(6), used in treatment was not returned for evaluation; thus, a visual and functional evaluation could not be performed, and a relationship between the reported event and the device could not be determined.A review of manufacturing and service records indicate the device met all specifications upon release into distribution.A complaint history review for similar reported/confirmed complaints has identified prior events.Although the reported problem was not confirmed, a factor that may have contributed to the reported symptoms may have been mechanical component failure, as the motor shaft wears over time, causing heat and noise.Although no further containment or corrective action is recommended or required at this time, all complaints are monitored and trended through post market surveillance activities.If the product associated with this event is returned or provided at a future date, this evaluation will be reopened for investigation.
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Search Alerts/Recalls
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