Cook Medical has issued a medical device correction for its Hemospray Endoscopic Hemostat, covering the HEMO-7, HEMO-10, HEMO-7-EU and HEMO-10-EU devices across all lots. The correction does not require removal of the devices from the field but updates the Instructions for Use (IFU) with additional preparation steps and precautions related to powder delivery and endoscope adherence.
The updated guidance addresses two issues. Hemospray powder can adhere to the distal end of the endoscope, potentially making repositioning or removal difficult, with increased risk when water-based lubricant is used, during retroflexion, or when withdrawing through narrowed anatomy. Powder can also compact during shipping or storage and prevent the device from spraying.
Endoscopy units are advised to keep the scope moving during and after application, irrigate with saline rather than sterile water if adherence occurs, and avoid rotating, pushing or pulling the scope until the powder is loosened. Staff should also follow revised powder-agitation instructions and update local competency materials.