SMITH & NEPHEW, INC. MOTOR DRIVE UNIT, HAND CNTRL, PWRMX EL; SAW, POWERED, AND ACCESSORIES
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Catalog Number 72200616 |
Device Problems
Overheating of Device (1437); Key or Button Unresponsive/not Working (4063)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/26/2024 |
Event Type
malfunction
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Event Description
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It was reported that during a procedure, the mdu was overheating and the buttons were not activating.The procedure was completed using a back-up device.There was no surgical delay and no further complications were reported.
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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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Internal complaint reference (b)(4).H3, h6: a device deficiency was not identified, and the root cause of the reported events 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 failures and/or harms were documented appropriately, and there were no indications to suggest the anticipated risks are 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 these events is returned at a future date, this investigation will be reopened for evaluation.
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Search Alerts/Recalls
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