. >> did olympus get fda preeivel? did it approval?no answers.ething called a 510k. >> so i think you have probably two things at work here. one, very generally, you want 510k approval because you want to get your new device on the market. >> you want to make money as soon as possible? >> absolutely. these are businesses. but you have something else that's at play. tweaking the device gives your about. so you're in a hotly quested and hotly contest ed arena. you say doc you need to buy two or four or six of these new devices immediately because we've made this excellent change. >> kaufman has named three sales reps in his lawsuit. olympus has not returned our calls. investigation of olympus devices found problems with keeping the devices clean even with the manufacturer's dleeng cleaning protocols. >> all the five outbreaks we discussed earlier, suggests that the hospitals were cleaning and disin effectingindisinfecting the devices. >> saying their product like all endoscopes, requires meticulous manual cleaning to ensure effective reprocessing.