Unit, Electrosurgical, Endoscopic (with Or Without Accessories)

Teslatome Bipolar Sphincterotomes

Due to product that may contain a void in the material that separates the wire guide and cutting wire lumens, which may cause an inappropriate path of current during cutting.

AXIOS Stent and Electrocautery-Enhanced Delivery System - 20mm x 10mm;

Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new one. The most serious reasonably foreseeable outcome in cases where the first flange is unable to deploy or expand would be a cascade of events resulting in additional intervention, either endoscopic or surgical, to remove the stent and close the puncture site.

AXIOS Stent and Electrocautery-Enhanced Delivery System - 6mm x 8mm;

Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new one. The most serious reasonably foreseeable outcome in cases where the first flange is unable to deploy or expand would be a cascade of events resulting in additional intervention, either endoscopic or surgical, to remove the stent and close the puncture site.

AXIOS Stent and Electrocautery-Enhanced Delivery System - 8mm x 8mm;

Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new one. The most serious reasonably foreseeable outcome in cases where the first flange is unable to deploy or expand would be a cascade of events resulting in additional intervention, either endoscopic or surgical, to remove the stent and close the puncture site.

HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 6mm x 8mm;

Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new one. The most serious reasonably foreseeable outcome in cases where the first flange is unable to deploy or expand would be a cascade of events resulting in additional intervention, either endoscopic or surgical, to remove the stent and close the puncture site.

*HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 8mm x 8mm;

Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new one. The most serious reasonably foreseeable outcome in cases where the first flange is unable to deploy or expand would be a cascade of events resulting in additional intervention, either endoscopic or surgical, to remove the stent and close the puncture site.

*HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 20mm x 10mm;

Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new one. The most serious reasonably foreseeable outcome in cases where the first flange is unable to deploy or expand would be a cascade of events resulting in additional intervention, either endoscopic or surgical, to remove the stent and close the puncture site.

Brand Name: CleverCut

Devices which did not undergo thermoforming could deform and lose performance.

Product Name: Single Use Sphincterotome V (Distal Wire guided)

Devices which did not undergo thermoforming could deform and lose performance.

Product Name: Disposable Triple Lumen Sphincterotome

Devices which did not undergo thermoforming could deform and lose performance.