This is a supplemental report to provide additional information.The subject device was returned to olympus medical systems corp.(omsc) for evaluation.The needle tube of the subject device was not returned.Omsc evaluated the subject device and found as follows; the outer tube of the subject device was kinked.The manufacturing record was reviewed and found no irregularities.This type of the event is most likely related to the operator's technique.Based on the past similar cases, it was known that the frictional resistance between the outer tube and the needle tube increased due to the kink of the needle tube, and then the needle could not be retracted into the outer tube.Also, the kink of the needle tube occurred due to applying load to the needle tube when the device was inserted into the endoscope, it was taken out from the sterile bag or pre-use inspection was performed.The instruction manual of the device has already warned as follows; *do not insert the instrument abruptly.This could cause patient injury, such as perforation, bleeding, or mucous membrane damage.It could also damage the endoscope and/or the instrument.*if using the same instrument several times in an operation, confirm there is no irregularity of the instrument before inserting it into the endoscope.
|