SMITH & NEPHEW, INC. MOTOR DRIVE UNIT HAND CNTRL PWRMX EL; SAW, POWERED, AND ACCESSORIES
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Model Number 72200616 |
Device Problems
Mechanical Jam (2983); Unexpected Shutdown (4019)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/29/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Internal complaint reference case (b)(4).The sample is under evaluation by the manufacturing site.
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Event Description
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It was reported that during use motor drive unit turned off when was being used.It is unknown if there was any delay or backup available; hence, it is unknown how the procedure was completed, no other complications were reported.Preliminary results of investigation found a jammed motor which makes it a reportable event.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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H10: h2, h3, h6.The reported device, used in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection found a broken lanyard.A functional evaluation found a jammed motor.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.The complaint was confirmed and the root cause has been associated with a mechanical component failure.Factors that could have contributed to the reported event include corrosion in the gearbox/motor assembly from cleaning and sterilization methods and the chemicals involved over a period of time or one or more of the motor phases shorting out.
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Search Alerts/Recalls
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