The mayfield modified skull clamp (a1059) was returned for evaluation: device history record (dhr) - the dhr was reviewed and shows no abnormalities related to the reported failure.Failure analysis - investigation showed that the unit does have a slight lateral and rotational movement, and a residue buildup was present.But when the clamp is properly positioned and put under pressure, it will not move.New components were added to replace worn internal parts, and general cleaning and maintenance were performed.Root cause - the complaint is not confirmed as repairs team could not duplicate loss of pressure.Probable root cause of the reported complaint is improper or suboptimal placement of the skull clamp on the patient.No further investigation is required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.At present, we consider this complaint to be closed.
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