THE SUBJECT DEVICE WAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION, BECAUSE THE SUBJECT DEVICE WAS ALREADY DISCARDED. THE LOT NO. WAS UNKNOWN. THEREFORE, AS THE RESULT OF CHECKING THE MANUFACTURING RECORD OF THE DEVICES WHICH HAD DELIVERED TO THE CUSTOMER DURING PAST ONE YEAR, THERE WAS NOTHING ABNORMAL FOUND. THE EXACT CAUSE COULD NOT BE CONCLUSIVELY DETERMINED. HOWEVER, BASED ON THE SIMILAR CASES IN THE PAST, THE NEEDLE TUBE MIGHT REMAIN EXTENDED FROM THE SHEATH OF THE SUBJECT DEVICE, BECAUSE THE SHEATH WAS KINKED. THE SHEATH MIGHT BE KINKED, BECAUSE EXCESSIVE LOAD WAS APPLIED TO THE SHEATH WHEN THE SUBJECT DEVICE WAS INSERTED INTO THE ENDOSCOPE, IT WAS TAKEN OUT FROM THE STERILE PACKAGE, OR IT WAS CHECKED 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.
D
Patient 1
DURING AN ENDOSCOPIC SUBMUCOSAL DISSECTION, THE SUBJECT DEVICE WAS USED. THE USER TEMPORARILY WITHDREW THE SUBJECT DEVICE FROM THE ENDOSCOPE. AFTER THAT, THE DOCTOR TRIED TO INSERT THE SUBJECT DEVICE INTO THE ENDOSCOPE AGAIN. AT THE TIME, THE NEEDLE TUBE OF THE SUBJECT DEVICE WAS STUCK TO THE NURSE BECAUSE THE NEEDLE TUBE WAS EXTENDED FROM THE SHEATH OF THE SUBJECT DEVICE. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THE NURSE HAD THE BLOOD TEST TO CONFIRM WHETHER THERE WAS INFECTIOUS DISEASE OR NOT. NO ABNORMALITIES HAVE BEEN REPORTED ABOUT THE NURSE. THE NURSE ALREADY RECOVERED.
Injector Force Max Single Use Injector (NM-400L); Injector Force Max Single Use Injector (NM-400U); Injector Force Max Single Use Injector (NM-400Y); Injector Force Max Single Use Injector (NM-401L)