Olympus Gets Another FDA Warning Letter for Failing to Address Duodenoscope Complaints
The FDA has issued another warning letter to Olympus Medical, indicating the company has ignored complaints over problems with its duodenoscopes.
Tag Archives: Olympus
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Olympus Gets FDA Warning Letter Over Failing to Meet Endoscope, Duodenoscope Medical Device Reporting Requirements
The FDA has issued warning letters to Olympus over a failure to meet quality control requirements, including reporting of complaints, involving its endoscope products.
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Infections Linked To Reprocessed Urological Endoscopes Under Investigation, FDA Announces
The FDA is warning that certain urological endoscopes have been linked to hundreds of infections and several deaths in recent years.
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FDA Calls For Duodenoscope Manufacturers To Create New Easier-To-Sterilize Designs
The FDA says current duodenoscope designs cannot be adequately cleaned, and are calling for hospitals to shift to designs that are disposable or have disposable components.
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Duodenoscopes May Be Impossible To Sterilize Safely and Need to be Recalled, Experts Tell NYT
Some medical experts are calling for duodenoscopes to be removed from the market, due to problems sterilizing them and the risk of patient infections.
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More Than 200 Duodenoscope Problems Reported to FDA Since October, But Number is Declining
The FDA received more than 200 adverse event reports linked to duodenoscopes since October, including 45 incidents of patient infections.
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Duodenoscopes Contamination Rates Still “Higher-Than-Expected”, FDA Officials Warn
The FDA warns that duodenoscopes are still showing higher-than-expected infection rates despite updated cleaning instructions and design changes.
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FDA Clears Custom Ultrasonics Reprocessors For Cleaning Some Duodenoscopes
The FDA has cleared Custom Ultrasonics AERs for the cleaning of some duodenoscopes, which have been linked to hospital infection outbreaks.
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Duodenoscope Manufacturers Get FDA Warning Letters For Falling Behind On Postmarketing Studies
The FDA has issued warning letters to the three manufacturers of duodenoscopes, warning that they have fallen behind on required postmarketing studies imposed after a number of infection outbreaks were…
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FDA Issues New Standardized Duodenoscope Protocols Following Infection Outbreaks, Recalls
The FDA has issued new voluntary protocols for hospitals to help ensure that duodenoscopes are properly cleaned and sanitized following a number of deadly hospital infection outbreaks in recent years.
