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FDA: Olympus waited years to report medical scope problems

24 Comments
By MATTHEW PERRONE

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24 Comments
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They should enclose the device in a flexible tube to keep the joint etc from getting dirty.

-2 ( +2 / -4 )

Some sort of single use latex covers are the first thing that come to my mind also. I wonder why aren't these multi use scopes implemented like this..

-1 ( +2 / -3 )

The FDA previously disclosed that Olympus did not seek federal clearance for the latest version of its duodenoscope, which it began selling in 2010.

Governance problems seems to be the least of their problems, seems like the entire company is a bunch of idiots and can't follow or understand any rules.

8 ( +10 / -2 )

sounds like the cleaning manual needs overhauling.

3 ( +3 / -0 )

They should enclose the device in a flexible tube to keep the joint etc from getting dirty.

It is. I have on of these Olymous scopes. I'm not entirely sure Olympus is to blame, these kind of problems are usually caused by improper sterilization.

5 ( +7 / -2 )

Missing is the published information that UCLA is currently in a testing program of the already FDA approved automated cleaning device from the Langford IC Systems and Proven Process. The automated system is designed to eliminate the need for hand cleaning of surgical instruments.

1 ( +1 / -0 )

I was about to ask "who cares?", because in Japan the CEOs of the company never, EVER suffer any consequences for putting profit over safety, or for cover-ups -- in fact, they just retire, get HUGE golden parachutes, and a high-paying job somewhere else through their other, also corrupt, connections -- but then I noticed this was caught in the US! GOOD! Now maybe the execs in the US branches will be put on the rack and the company legitimately sued (not just a 10% pay dock for a month or something).

Is it any wonder that in Japan they changed the name of the recent Hollywood movie from "Olympus Has Fallen"? They don't want attention drawn to the facts even by coincidence.

7 ( +11 / -4 )

FDA: Olympus waited years to report medical scope problems

OK. Who lost the ringisho?

0 ( +0 / -0 )

Improper sterilization in American hospitals and they blame a company? The US is always a surprise. Try to control how they clean the device, this kind of problem is related to sterelization.

-10 ( +3 / -13 )

Regardless , it's great that we have people in Microbiology making discoveries like this, as human beings we continue to fix and mend our mistakes.

1 ( +1 / -0 )

@Alex80 Glad you got that covered doc.

Additionally, FDA inspectors found that the company has no standard procedure for promptly reporting serious problems with its devices, a requirement for medical device companies.

No need to report stuff. Alex80 has it covered.

1 ( +2 / -1 )

Alex80: "The US is always a surprise."

Here you go again, blaming the US when a Japanese company has falsified information and data about a product, and this is only coming to light because the SAME company (that's right, Alex, a Japanese company!) is facing scrutiny for other scandals.

But nope, just like with Takada airbags and the companies cover-ups from the top, you blame the US.

4 ( +7 / -3 )

I repeat, only in the US. Weird.

0 ( +0 / -0 )

Lets all give a round of applause to Olympus!!! They waited YEARS to make a report,so what right?? As long as no one noticed any irregularities,no harm no foul right?? Other companies would have just waited....if something did come up...deny it...if evidence came out proving them wrong...they would simply hold a press conference and BOW deeply and do the obligatory "gomen-nasai"

-2 ( +0 / -2 )

Smithiniapan. The FDA aproved those devices. Looks like nobody knew about those bacteria. The fun part is that olympus is the only company in the world that makes it thats why fda said to keep them.

2 ( +2 / -0 )

There's been a couple of hospitals in Japan that have recently had their licences cut for performing operations due to patients dying from infections. I'm wondering if these devices could be part of the problem.

0 ( +2 / -2 )

I was saying why only in the US? The same devices are used worldwide. Sorry but it's too much wierd. They should control the hospitals. And stop censor my posts like ot. This is why the EU shouldn't accept the Ttip.

-1 ( +1 / -2 )

So, they cleaned badly the tools and they blame Olympus...?! It seems comfortable...

-4 ( +0 / -4 )

overchan: Things often get approval when facts are omitted, and it clearly states that on a number of occasions Olympus failed to report things, that they even failed to get clearance before selling the latest version, and that they don't even have a company procedure in place for reporting serious problems with equipment.

So, how is this the US' fault again?

Alex80: "I was saying why only in the US? The same devices are used worldwide."

Perhaps the FDA is the only organization to find the root of the problem.

0 ( +4 / -4 )

Medical device manufacturers are required to report serious device problems to the FDA within 30 days of learning about them.

What does it mean? 1 out of 10 for foreign companies compared to 1 out 100 from US manufacturer? U.S. Satandards are are normally very poor.

-1 ( +0 / -1 )

FDA should know that It was their fault. Bacteria can get inside many tools. Even when properly cleaned. But thats life. Life is not perfect.

-5 ( +0 / -5 )

The scary thing is how some people blindly trust these American "controllers"as they were gods, just because they are American. Then you see for example Moodys, Standard and Poors, Fitch double standard and you understand that like in finance world, also in any other context there are double standard for sure but nobody is strong enough to opposite to them. This is why Ttip and Tpp are dangerous for all the countries involved except for the US. I don't trust FDA or any other American "controllers" that find any reason good to fine foreign companies and destroy financially whole countries.

-5 ( +0 / -5 )

@Alex80 Don't "blindly trust" anyone. Now who is destroying "whole countries"? I missed that part but I'd sure like to know.

3 ( +3 / -0 )

Smithinjapan. They don't have report prcedures simply because they don't have to. The scopes are not faulty. Its just that some bacteria didn't die with the cleaning procedure. What is olympus going to do? Recall them each when a new bleach resistant bacteria comes out? LikebI said. Life is not perfect. FDA didnt oversee about this bacteria. EVER.

-1 ( +0 / -1 )

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