The central service tech was assembling cystoscopy trays and noticed that the black plastic tip located on the distal end of the 17 fr, rigid cystoscope obturator had fallen off.The "tip" assist introducing the rigid cystoscope through the urethra into the bladder.Once the cystoscope is introduced, the obturator with the plastic tip can be removed and the scope with a camera can then be inserted.The safety concern was discovered before the cystoscope obturator was used during a cystoscope procedure.All tips are manually being inspected to ensure that plastic tip can't be removed / pulled off.Olympus medical systems corporation, (b)(4).Fda safety report id# (b)(4).
|