Hemostatic Device For Endoscopic Gastrointestinal Use

Cook Medical HEMO-7-EU Hemospray Endoscopic Hemostat, REF G24663, 2.8 cm, sterile.

Specific lots of product have been manufactured with nonconforming raw materials resulting in the red activation knob cracking or breaking at the activation knob internal threading while the device is activated.

Cook Medical Hemo-7 Hemospray Endoscopic Hemostat, REF G56572, 2.8 mm, Sterile; and Hemo-10 Hemospray Endoscopic Hemostat, REF G21049, 3.7 mm, Sterile. The devi

Specific lots of product have been manufactured with nonconforming raw materials.

Hemospray Endoscopic Hemostat: Reference Part Numbers: a) HEMO-7, REF G56572; b) HEMO-7-EU, REF G24663;

There are potential risks of the Hemospray powder adhering to the distal end of the endoscope, which can result in adhesion of the endoscope to tissue and consequent difficulty or inability to maneuver/remove the endoscope.

Hemospray Endoscopic Hemostat: Reference Part Numbers: a) HEMO-10, REF G21049; b) HEMO-10-EU, REF G21346

There are potential risks of the Hemospray powder adhering to the distal end of the endoscope, which can result in adhesion of the endoscope to tissue and consequent difficulty or inability to maneuver/remove the endoscope.

HEMO-7 Hemospray Endoscopic Hemostat

Complaints that the handle and/or activation knob on Hemostat devices have cracked or broken when the device is activated. In some cases, this has caused the carbon dioxide cartridge to exit the handle. Most of these complaints reported that the carbon dioxide cartridge exited the handle with minimal force. However, some complaints reported that the carbon dioxide cartridge exited the handle with the potential to project towards a user or a patient.

HEMO-10 Hemospray Endoscopic Hemostat

Complaints that the handle and/or activation knob on Hemostat devices have cracked or broken when the device is activated. In some cases, this has caused the carbon dioxide cartridge to exit the handle. Most of these complaints reported that the carbon dioxide cartridge exited the handle with minimal force. However, some complaints reported that the carbon dioxide cartridge exited the handle with the potential to project towards a user or a patient.

Hemospray Endoscopic Hemostat

Potential for Hemospray device to be unable to spray powder due to misassembly of devices.