Post-market Clinical Follow-up Study Plan for Disposable Endoscopic Linear Cutter Stapler

Post-market Clinical Follow-up Study Plan for Disposable Endoscopic Linear Cutter Stapler

This study conducted a Post-Market Clinical Follow-Up study (PMCF) to evaluate the safety and effectiveness of the disposable endoscopic linear cutter stapler produced by Changzhou Ankang Medical Instrument Co., Ltd., through a retrospective analysis of the clinical data, to evaluate the safety and effectiveness of soft tissue resection, transection and anastomosis.

Inclusion Criteria:

• Age unlimited and gender unlimited;
• The surgery type shall be endoscopic surgery;
• The departments of surgical procedures: general and thoracic surgical procedures;
• Investigational devices of all the models of the staplers and its cartridge listed in Section 2.3.

Exclusion Criteria:

• Patients undergoing surgery for contraindications to the product, such as severe mucosal edema, non-observation of hemostatic sites for surgery or off-label use, such as liver and spleen;
• Combined with other similar products (stapler) for resection, transection and anastomosis of the surgical site;
• Surgery record is incomplete, unable to extract main indicators related information.