40 results

• Olympus Endoscope Guide Sheath Recall Issued After Multiple Injuries Linked to Tip Detachment

  March 4, 2025

  Michael Adams

  Federal health officials are announcing a recall of certain Olympus endoscope single use guide sheath kits, after dozens of serious injuries have been reported from tips detaching inside patients during examinations.

• Olympus Endoscope Components Linked to 120 Patient Injuries and 1 Death, FDA Warns

  December 30, 2024

  Martha Garcia

  The FDA is warning that some Olympus endoscope parts may cause serious infections if not cleaned properly, which has already led to more than 100 patient infections and at least one death.

• Olympus Gets Another FDA Warning Letter for Failing to Address Duodenoscope Complaints

  March 20, 2023

  Martha Garcia

  The FDA has issued another warning letter to Olympus Medical, indicating the company has ignored complaints over problems with its duodenoscopes.

• Disposable Duodenoscope Elevator Caps Appear Effective in Preventing Infections, Study Finds

  January 25, 2023

  Irvin Jackson

  A new study appears to confirm the effectiveness of disposable elevator caps in preventing duodenoscopes from passing infections from one patient to another.

• Olympus Gets FDA Warning Letter Over Failing to Meet Endoscope, Duodenoscope Medical Device Reporting Requirements

  January 12, 2023

  Irvin Jackson

  The FDA has issued warning letters to Olympus over a failure to meet quality control requirements, including reporting of complaints, involving its endoscope products.

• FDA Calls For Full Transition To Disposable Duodenoscopes Due to Infection Risks

  April 7, 2022

  Irvin Jackson

  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.

• Karl Storz Endoscope Recall Issued Over Inadequate Sterilization Process

  April 5, 2022

  Irvin Jackson

  The FDA warns that instructions for cleaning dozens of models of Karl Storz urological endoscopes is insufficient, and could leave patients vulnerable to infections.

• Infections Linked To Reprocessed Urological Endoscopes Under Investigation, FDA Announces

  April 2, 2021

  Irvin Jackson

  The FDA is warning that certain urological endoscopes have been linked to hundreds of infections and several deaths in recent years.

• Cross Contamination, Infection Risk From Arthroscopy Pump Tubing Sets Results in FDA Guidance

  January 29, 2020

  Martha Garcia

  The FDA has issued a new draft guidance on how arthroscopy tubing sets can be designed to prevent transfer of infectious materials between patients.

• Hospitals Should Transition To Disposable Duodenoscopes Or Those With Disposable Parts: FDA

  January 16, 2020

  Irvin Jackson

  The FDA urges hospitals to start using duodenoscopes that are fully disposable or use disposable parts to protect their patients from potential infections.