Catalog Number 0375704500 |
Device Problem
Overheating of Device (1437)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 03/05/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Additional information will be provided once the investigation has been completed.
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Event Description
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It was reported that the product got hot.
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Manufacturer Narrative
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Alleged failure: the shaver got way to hot to use, had to swap out the unit.The failure alleged in the complaint record was not confirmed/duplicated during the product investigation.The probable root causes could be (1) excessive force applied to the cutter/burr by the user with poor or no suction during use.Excessive force may cause friction due to bur shaft assembly and housing assembly interaction.(2) tissue blocking the suction pathway would prevent hot fluid from being removed from the joint.(3) poor arthroscopy pump suction.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.
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Event Description
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It was reported that the product got hot.
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Search Alerts/Recalls
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