SMITH & NEPHEW, INC. MOTOR DRIVE UNIT HAND CNTRL PWRMX EL; SAW, POWERED, AND ACCESSORIES
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Catalog Number 72200616 |
Device Problems
Protective Measures Problem (3015); Physical Resistance/Sticking (4012); Intermittent Energy Output (4025)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/01/1901 |
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.There was a relationship found between the returned device and the reported incident.A visual inspection was performed on the product and no issue was observed.A functional evaluation revealed a handpiece error and stuck button.The complaint was confirmed and the root cause has been associated with a mechanical component failure.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.Factors that could have contributed to the event include a buildup of corrosion/debris around the spring from cleaning chemical fluid ingression over time.
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Event Description
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It was reported that the motor drive unit, hand cntrl, pwrmx el turns itself on and off.No case reported; therefore, there was no patient involvement.Results of investigation have concluded that this unit left button was stuck and would not activate the motor causing a hand piece error which makes it a reportable event.
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Search Alerts/Recalls
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