SMITH & NEPHEW, INC. MOTOR DRIVE UNIT HAND CNTRL PWRMX EL; SAW, POWERED, AND ACCESSORIES
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Model Number 72200616 |
Device Problem
Activation Problem (4042)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 07/14/2020 |
Event Type
malfunction
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Event Description
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It was reported that, during surgery, all the three buttons of the "mdu powermax elite shaver" were not working.A button of the handpiece could not be pressed properly, thus this caused trouble in operating the shaver.The procedure was successfully completed without delay using a back-up device.No patient injuries or other complications were reported.
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Manufacturer Narrative
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The reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.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.A relationship, if any, between the subject device and the reported event could not be determined.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.If the product associated with this event is returned at a future date, this evaluation will be re-opened for investigation.
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Search Alerts/Recalls
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