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: Endoscope
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Disposable Duodenoscope Elevator Caps Appear Effective in Preventing Infections, Study Finds
A new study appears to confirm the effectiveness of disposable elevator caps in preventing duodenoscopes from passing infections from one patient to another.
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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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FDA Calls For Full Transition To Disposable Duodenoscopes Due to Infection Risks
The FDA says disposable duodenoscopes should be adopted by every hospital in the U.S. to cut down on infection risks linked to the endoscopic devices.
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Karl Storz Endoscope Recall Issued Over Inadequate Sterilization Process
The FDA warns that instructions for cleaning dozens of models of Karl Storz urological endoscopes is insufficient, and could leave patients vulnerable to infections.
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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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Cross Contamination, Infection Risk From Arthroscopy Pump Tubing Sets Results in FDA Guidance
The FDA has issued a new draft guidance on how arthroscopy tubing sets can be designed to prevent transfer of infectious materials between patients.
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Hospitals Should Transition To Disposable Duodenoscopes Or Those With Disposable Parts: FDA
The FDA urges hospitals to start using duodenoscopes that are fully disposable or use disposable parts to protect their patients from potential infections.
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First Fully Disposable Duodenoscope Approved By FDA
The FDA has approved the first fully disposable duodenoscope in an effort to eliminate the risk of infections linked to ineffective sterilization techniques.
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FDA Hopes Duodenoscope With Disposable Elevator Will Solve Sterilization Problems
The FDA has approved the first duodenoscope with a disposable elevator tip, which should reduce infection risks.
