The FDA said today that is looking into the causes of infections from reprocessed urological endoscopes based on “numerous” adverse event reports. The agency said that since 2017 it has received more than 450 medical device reports — including three deaths — associated with reprocessed cystoscopes, ureteroscopes and cystourethroscopes used for viewing and accessing the […]
Karl Storz
Owens & Minor’s ArcRoyal warns of excess ethylene oxide in tubing sets
Owens & Minor (NYSE:OMI) company ArcRoyal issued an urgent field safety notice in Europe to warn of an issue with ethylene oxide (EtO) residue in custom procedure trays that contain an insufflation tubing set with gas from Karl Storz. Karl Storz initiated the recall, noting that the affected products contained increased residues of the carcinogenic sterilant […]
Medtronic hints at upcoming surgical robot
Medtronic (NYSE:MDT) won’t unveil its new robot-assisted surgery platform until the fall, but a recent announcement from the company offered a sneak peek at what’s coming. The medical device giant yesterday disclosed a partnership with Karl Storz SE & Co. (Tuttlingen, Germany) to use Karl Storz’s three-dimensional vision systems and visualization components into Medtronic’s upcoming robot-assisted […]
Steris, Karl Storz win $350m+ DoD contract extensions for integrated OR products
Steris (NYSE:STE) and Karl Storz have each won supply contract extensions with the U.S. Department of Defense worth over $350 million to supply the agency with integrated operating room components, accessories and services, according to a recently posted DoD release. Ireland-based Steris won a maximum $393.8 million contract to supply the Army, Navy, Air Force, Marine […]
Mauna Kea looks to Medtronic, Stryker, others for help in commercializing Cellvizio
Mauna Kea (ENT:MKEA) founder & CEO Sacha Loiseau is looking to some of the biggest names in medtech for help in commercializing its Cellvizio device in the U.S. after winning 510(k) clearance from the FDA last month. Paris-based Mauna Kea could ink a deal by the end of the year that would allow it to speed Cellvizio to market […]
