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Class 1 Device Recall Olympus MAJ891 Forceps/Irrigation Plug (Isolated Type) FDA Home Medical Devices Databases
4 thg 2, 2025 · In recent weeks, the Food and Drug Administration (FDA) has issued a severe judgment regarding an endoscope accessory manufactured by Olympus, the model MAJ-891. This recall has been classified as a Class I, which is reserved for devices posing a risk of death or serious injuries in case of use or non-compliance.
23 thg 12, 2024 · The FDA is aware that Olympus has issued a letter to affected health care providers recommending the forceps/irrigation plug accessory to certain endoscopes be removed from use related to a potentially high-risk device issue with …
The FDA has classified Olympus’ recall of the MAJ-891 forceps/irrigation plug as a Class I recall—the most serious designation—following reports of 120 injuries and one death linked to improper reprocessing of the device. Though Olympus discontinued the accessory in the U.S. in 2022, healthcare providers may still be using it, prompting the company to recommend …
30 thg 1, 2025 · Olympus assessed the issue after receiving complaints of adverse events involving patient injuries and one death. The potential harm of improper and/or incomplete reprocessing of the MAJ-891 Forceps/Irrigation Plug is exposure to a contaminated device, which could result in patient injury; specifically, infection. Olympus notified U.S. customers about this matter by letter …
California Device Recall Information Sheet Food and Drug Branch – Device Recalls Olympus Corporation of the Americas Olympus MAJ-891 Forceps/Irrigation Plug ... For additional information, please visit the FDA Website.
18 thg 12, 2024 · Olympus is sending an advisory notice pertaining to the Forceps/Irrigation Plug (Isolated Type) model MAJ-891 (“MAJ-891”). The MAJ-891 is attached to the instrument channel port of certain Olympus endoscopes, including cystoscopes (CYF series), ureteroscopes (URF series), choledochoscopes (CHF series), and hysteroscopes (HYF series) to allow both irrigation …
3 thg 2, 2025 · The December early alert, part of a pilot effort to inform the public sooner about potential device problems, came five days after Olympus notified customers that improper reprocessing of the part, called a forceps/irrigation plug model MAJ-891, could lead to infection.
30 thg 1, 2025 · Olympus Corporation has announced a voluntary Advisory Notice for the Forceps/Irrigation Plug (Isolated Type) model MAJ-891 related to the risk of device contamination that may result from ...
In January 2025, Olympus Corporation announced a voluntary advisory notice and Class 1 recall for its endoscope accessory, the Forceps/Irrigation Plug (Isolated Type) model MAJ-891 because of the risk of contamination. People who suffered infections from using the device may be eligible to file an Olympus endoscope lawsuit.
31 thg 1, 2025 · RELATED: Olympus Launches New Powerseal Jaw Designs Potential Harm and Reported Adverse Events Olympus assessed the issue after receiving complaints of adverse events involving patient injuries and one death. The potential harm of improper and/or incomplete reprocessing of the MAJ-891 Forceps/Irrigation Plug is exposure to a contaminated device, …
5 thg 3, 2025 · Update on Alert: Endoscope Accessories Forceps/Irrigation Plug Issue from Olympus This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program.
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