SMITH & NEPHEW, INC. MOTOR DRIVE UNIT, HAND CNTRL, PWRMX EL; SAW, POWERED, AND ACCESSORIES
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Catalog Number 72200616 |
Device Problems
Display or Visual Feedback Problem (1184); Overheating of Device (1437)
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Patient Problem
No Patient Involvement (2645)
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Event Date 12/03/2018 |
Event Type
malfunction
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Event Description
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It was reported that about 45 minutes into the case, the shaver started changing speed between 2500 revolutions and 10000 revolutions.It started showing an ¿unknown handpiece¿ failure error.Additional information was received and was confirmed that the device overheated.No patient injury or significant delay were reported.Back up device was available.
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Manufacturer Narrative
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(b)(6).The reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A relationship, if any, between the subject device and the reported event could not be determined.A review of the device history record shows there are no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.
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Search Alerts/Recalls
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