It was reported that, due to the cook-swartz doppler probe not working correctly, the patient was taken back to the operating room for a free-flap revision surgery.Once the operation started, the physician found that the crystal was detached from the probe.This additional procedure resulted in a longer hospital stay for the patient.No other patient consequences were reported.
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Blank fields on this form indicate information is unknown or unavailable.Investigation/evaluation summary: the device was inspected under magnification and confirmed the customer's complaint that the cuff became detached from the crystal.A functional test was performed on the probe and an audible pulse sound was verified.A functional test was performed on the probe and, when connected to the doppler monitor, the audible pulse signal was able to be verified on both sides of the crystal.No other nonconformities or anomalies were observed.A review of the device history record and manufacturing and quality control records was conducted.There is no evidence that defective product was manufactured using current drawings and device specifications.Complaints will continue to be monitored according to established complaint monitoring procedures.
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