SMITH & NEPHEW, INC. DYONICS POWERMINI, WITH HAND CONTROLS; SAW, POWERED, AND ACCESSORIES
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Catalog Number 72201500 |
Device Problem
Overheating of Device (1437)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/02/2024 |
Event Type
malfunction
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Manufacturer Narrative
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H10: internal complaint reference number: (b)(4).
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Event Description
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It was reported that, during set up for a procedure, the dyonics powermini got hot when plugged in.There was a back-up device available and no delay was reported.There was no patient involvement.
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Manufacturer Narrative
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H10: internal complaint reference (b)(4).H3, h6: a device deficiency was not identified, and the root cause of the reported event could not be determined since the device was not returned for evaluation.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found similar reported events.A risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.Please refer to the instructions for use for precautions and warnings related to the use of the device.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.
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Search Alerts/Recalls
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