There has been a previous report received with a similar device where this malfunction resulted in a serious injury.Therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such.As such, this event is reportable per 21cfr part 803.Before use, the device won't hold file firmly.The engineer of the hospital found that the head part of device was worn, which led to can't hold file firmly.Equipment has been repaired.After the test performance is qualified, it has been returned to the doctor for normal use.All complaints are monitored through the monthly product surveillance committee and a corrective action could be determined by the committee.
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