SMITH & NEPHEW, INC. MOTOR DRIVE UNIT HAND CNTRL PWRMX EL; SAW, POWERED, AND ACCESSORIES
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Catalog Number 72200616 |
Device Problem
Power Problem (3010)
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Patient Problem
Insufficient Information (4580)
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Event Date 01/01/1901 |
Event Type
malfunction
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Manufacturer Narrative
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The reported device, intended for use in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection was performed on the product and observed no issues.A functional evaluation revealed a blade stall.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.A complaint history review concluded this was a repeat issue.The complaint was confirmed and the root cause has been associated with a mechanical component failure.Factors that could have contributed to the reported event include corrosion in the gearbox/motor assembly from cleaning and sterilization methods and the chemicals involved over a period of time or one or more of the motor phases shorting out.
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Event Description
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It was reported that, the "mdu powermax elite shaver" was not working.It is unknown if the event happened during surgery.Therefore, no patient involvement or surgical complications could be confirmed.No further information is available.Results of investigation have concluded that this unit had a blade stall which makes it a reportable event.
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Search Alerts/Recalls
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