During an injection procedure, the needle tube of the subject device could not be extended from the sheath.Eventually, the needle tube was extended from the sheath.The doctor completed the procedure with the subject device.After the procedure, he attempted to retract the needle tube into the sheath, but the needle tube could not be retracted.Therefore the doctor withdrew the subject device from the patient while extending needle tube.No patient injury was reported.
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This supplemental report is being submitted to provide additional information.The subject device was returned to olympus medical systems corp.(omsc) for evaluation.The needle tube was not correctly extended and retracted.The sheath of the subject device was kinked.As the result of checking the manufacturing record of the same lot, there were nothing abnormal found.Based on the similar cases in the past, it is known that the needle tube could not be retracted into the sheath due to kink of the sheath.The kink of the sheath might be caused by the excessive load applied to the sheath when inserting the subject device into the endoscope, taking out the subject device from the sterile package, or in checking before use.The instruction manual of the subject device warns; *when inserting the instrument into the endoscope, retract the needle into the sheath, hold the instrument close to the biopsy valve, and keep it as straight as possible relative to the biopsy valve.Otherwise, the instrument could be damaged.*before use, inspect the insertion portion and the tube for damage.
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