SMITH & NEPHEW, INC. MOTOR DRIVE UNIT NON-HAND CNTL PWRMX; SAW, POWERED, AND ACCESSORIES
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Model Number 72200617 |
Device Problem
Connection Problem (2900)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 06/22/2020 |
Event Type
malfunction
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Event Description
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It was reported that, during a shoulder arthroscopy, the "mdu powermax elite shaver" was not being recognized by the shaver console, additionally, sometimes it stopped working and displays that the shaver was unplugged.In consequence, it was unplugged and it worked again.The procedure was successfully completed without delay using a back-up device.No patient injuries or other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
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Manufacturer Narrative
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The reported device, used in treatment, was received for evaluation.There was no relationship found between the returned device and the reported incident.A visual inspection was performed on the product and no issue was observed.Complaint of recognition failure could not be reproduced.Product passed functional and high speed testing (100-10,000 rpms) for 5 minutes each in forward, reverse and oscillate directions.Unit passed functional tests on the dii and dii eip test control units with and without footswitch.Mdu recognition failure did not occur during functional testing.The complaint was not confirmed and the root cause could not be determined since the reported malfunction could not be duplicated during the product evaluation process.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.
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Search Alerts/Recalls
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