Catalog Number 72200616 |
Device Problems
Display or Visual Feedback Problem (1184); Overheating of Device (1437)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 01/01/1901 |
Event Type
malfunction
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Event Description
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It was reported that the device shows an error message and overheated.It is unknown if the event happened during a procedure and if there was a delay or backup available.
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Manufacturer Narrative
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The device was received for evaluation.A visual inspection was performed on the product and no issue was observed.There was a relationship found between the returned device and the reported incident.Product failed functional testing with blade stall error and overheating.Cause of overheating and errors is a corroded motor/gearbox.The motor/gearbox assembly was removed from the housing and the gearbox was removed from the motor.The gearbox was found to be jammed.The complaint was confirmed and the root cause has been determined to be corrosion of the motor and gearbox assembly.A blade stall condition will result in increased current draw from the control unit which will heat the motor and hand piece housing.Factors which can contribute to gearbox corrosion include cleaning and sterilization methods and the chemicals involved.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.
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Event Description
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It was reported that, during an unspecified surgery, the device showed an error message and overheated.A back-up device was available to complete the procedure without significant delay.Neither the patient nor the user was injured as consequence of the alleged malfunction.
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Search Alerts/Recalls
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