#United States #Medical Device #Center Valley #Olympus #MAJ-891

Olympus Issues Advisory for Medical Device MAJ-891

Olympus Corporation has recently released a voluntary advisory notice for their Forceps/Irrigation Plug (Isolated Type) model MAJ-891 following concerns over potential contamination risks associated with improper reprocessing methods. This accessory is utilized in various Olympus endoscopes, including cystoscopes (CYF series), ureteroscopes (URF series), choledochoscopes (CHF series), and hysteroscopes (HYF series). While the MAJ-891 was phased out of the U.S. market in 2022, the device remains in use by customers who purchased it prior to its discontinuation.

The advisory was prompted by reports of adverse events, which include patient injuries and, tragically, one confirmed death that could be linked to the MAJ-891. Olympus evaluated the complaints and determined that the hazards stemmed from unsuitable reprocessing of the device, which poses a significant risk of contamination, leading to possible infections in patients.

In a letter sent to U.S. customers on December 18, 2024, Olympus recommended immediate action to mitigate these risks. The company strongly advises users to switch to available alternative devices for the MAJ-891 when using Olympus cystoscopes and ureteroscopes. Currently, however, there are no equivalent Olympus irrigation plugs approved for use with the choledochoscopes and hysteroscopes, leaving customers to either find an alternative endoscope or opt for a non-Olympus irrigation plug, provided that it is validated for use with Olympus endoscopes by the respective manufacturer.

For users who cannot find alternative solutions for the MAJ-891, it remains crucial to strictly adhere to the reprocessing protocols outlined for both the endoscope and the MAJ-891 unit. This includes segregating the MAJ-891 from the endoscope’s instrument channel port and meticulously cleaning, disinfecting, and sterilizing it before use. This precautionary measure is vital to avoid exposure to potentially contaminated equipment that may jeopardize patient safety.

In addition, Olympus encourages healthcare professionals to report any adverse reactions or quality concerns regarding the use of these devices via the FDA’s MedWatch program. Reports can be submitted online to ensure that all safety issues are documented and addressed. Further assistance can be sought from the Olympus Technical Assistance Center, which can be reached at 800-848-9024 or through their designated email channel.

Olympus’s commitment remains steadfast in enhancing healthcare practices by producing effective medical devices, with a focus on patient safety and optimal treatment outcomes. With over a century of experience in the field, the company aims to partner with healthcare providers to ensure that tools and technologies meet the highest standards of care. As Olympus navigates this crucial alert, they continue to prioritize the health and well-being of patients across the globe. For comprehensive information about their product offerings and healthcare solutions, visit olympusamerica.com.

In conclusion, healthcare providers utilizing Olympus products should remain vigilant and responsive to this advisory to uphold the safety and health standards expected in medical practices. All stakeholders are encouraged to engage proactively in monitoring and reporting any safety issues relating to these essential medical devices.