A facility reported that during assembly of the crw precision arc system-pool (crwprecisep) for a deep brain stimulation procedure, it was noted that the lateral slide screw which is normally captured had been fully detached and the lateral slide lock removed and was missing within the sterilization tray.This resulted in the case being delayed for 2 hours, with no adverse consequence to the patient.
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Crw precision arc system (crwprecisep) was not returned for evaluation and lot number information has not been provided; therefore, an evaluation of the device could not be performed, and manufacturing records could not be reviewed.Based on information reported, root cause appears to be improper setup, however this is unconfirmed due to the fact that the product has not been returned for evaluation.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.
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