Ligator, Esophageal

Brand Name: Single Use Ligating Device

Potential that the ligation loop was unable to release or detach as expected during use, causing the loop to become unintentionally fixed around patient anatomy.

Single Use Rotatable Clip Fixing Device

There have been complaints that the clip did not come out of the tube sheath during the procedure.

Disposable Hemostasis Clip, DCH-7-230, Rx only, Single Use only, Cook Medical

The disposable clip may not deploy after being positioned inside the patient.

Six Shooter Saeed Multi-Band Ligator, Rx Only, Wilson Cook Medical 4900 Bethania Station Road, Winston-Salem, NC 27105

A section of the ligator barrel may separate from the barrel's friction fit adapter that attaches to the patent end of the endoscope. This could result in a section of the ligator barrel detaching inside the patient's gastrointestinal tract.

Elastic Traction Device, 11mm Lower. UPN: ER56041

FDA has informed Micro-Tech that the Elastic Traction Device is not appropriately classified as a Class I device and requires 510(k) clearance to be marketed in the US.