SMITH & NEPHEW, INC. MOTOR DRIVE UNIT, HAND CNTRL, PWRMX EL; SAW, POWERED, AND ACCESSORIES
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Model Number 72200616 |
Device Problem
Failure to Shut Off (2939)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/12/2022 |
Event Type
malfunction
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Event Description
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It was reported that the mdu was not turning off.No case was reported; therefore, there was no patient involvement.
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Manufacturer Narrative
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Internal complaint reference: (b)(4).
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Manufacturer Narrative
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H10: internal complaint reference: (b)(4).H3, h6: the reported device was received for evaluation.A visual inspection found no issues.A functional evaluation revealed no problems.Product passed all functional tests.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 failure was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.The root cause was not determined since the reported malfunction could not be duplicated during the product evaluation process.Factors that can contribute to the reported event include a buildup of corrosion/debris around the spring from cleaning chemical fluid ingression over time.No containment or corrective actions are recommended at this time.
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Search Alerts/Recalls
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