SMITH & NEPHEW, INC. MOTOR DRIVE UNIT HAND CNTRL PWRMX EL; SAW, POWERED, AND ACCESSORIES
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Catalog Number 72200616 |
Device Problems
Failure to Power Up (1476); Protective Measures Problem (3015); Physical Resistance/Sticking (4012)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/25/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Internal complaint reference: (b)(4).The reported device, intended for use in treatment, was received for evaluation.A visual inspection was performed on the product and red dot on connector was worn off.There was a relationship found between the returned device and the reported incident.Product failed functional testing with handpiece error.Cause of error is a stuck button.The complaint was confirmed and the root cause has been determined to be a stuck button.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.
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Event Description
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It was reported that, during set up for surgery, when the "mdu powermax elite shaver" was plugged in into the console, it showed a handpiece error.A backup device was available to complete the procedure.There were no procedural delays and no patient injuries or other complications were reported.Results of investigation have concluded that this unit had a failed button that would not activate the motor which makes it a reportable event.
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Search Alerts/Recalls
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