SMITH & NEPHEW, INC. MOTOR DRIVE UNIT HAND CNTRL PWRMX EL; SAW, POWERED, AND ACCESSORIES
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Model Number 72200616 |
Device Problems
Leak/Splash (1354); Self-Activation or Keying (1557)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/04/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Internal complaint reference: (b)(4).
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Event Description
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It was reported that during a shoulder arthroscopy acromioplasty, after the patient was moved to the operating room and the procedure began, the shaver started to operate by itself without surgeon's activation.The surgeon stopped the device and removed the tip, black oil came out of the device and dripped onto the operating table.The procedure was completed with a non-significant delay using a backup device.No further complications were reported.
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Manufacturer Narrative
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H3, h6: the reported device was received for evaluation.A visual inspection found a discolored cable.A functional evaluation was performed on the returned device and a noisy motor was found.The motor/gearbox could not be removed from the housing for further assessment.Self-activation and leaking were not noted during testing.It was determined the device contributed to the reported event.The complaint of self-activation was not confirmed.Factors that could have contributed to the reported event include a failure of a concomitant device.The complaint of black oil leaking was not confirmed.The noisy motor was confirmed, and the root cause was associated with a mechanical component failure.Factors that could have contributed to the failure include corrosion in the gearbox/motor assembly from cleaning and sterilization methods and the chemicals involved over a period of time or a short in the power cord.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.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review found similar reported events.A risk management review found that the reported failures were documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.No containment or corrective actions are recommended at this time.Correction in h6 (medical device problem code).
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Event Description
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It was reported that during a shoulder arthroscopy acromioplasty, after the patient was moved to the operating room and the procedure began, the shaver started to operate by itself without surgeon's activation.The surgeon stopped the device and removed the tip, black oil came out of the device and dripped onto the operating table.The procedure was completed with a non-significant delay using a backup device.No further complications were reported.As per investigation results, noisy motor was found.
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Search Alerts/Recalls
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