It was reported that during set up or inspection, the dii controller had a problem with the shaver, it got burned, the disposable tip of the shaver got very hot.There was no sparks, smoke or arcing.There was no damaged or burned caused to the patient/user.The procedure was completed with a s+n back up device.There was no surgical delay and no further complications were reported.
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H10: internal complaint reference (b)(4).H3, h6: the reported device was received for evaluation.A visual inspection was performed on the exterior of product and no physical damage was observed.The reported malfunction was not duplicated during functional testing.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.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 failure of a concomitant device.No containment or corrective actions are recommended at this time.
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