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.
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.
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.
For patients who need to be operated for abdominal, gynecologic, pediatric, and thoracic, endoscopic (i.e., endo-therapy) surgery for the expeditious transection/resection of tissues and creation of anastomoses.
Cohort
Retrospective
Disposable endoscopic linear cutter stapler
DeviceInvestigational devices of all the models of the staplers and its cartridge listed in Study Plan(Plan number: CAK-PMCF)
Anastomosis success rate
The condition of no reoperation in situ was defined as successful anastomosis as determined by surgical records and hospitalization medical records.
Operation time
Confirmed by surgical records and anesthesia sheets.
Amount of intraoperative blood loss
Confirmed by surgical records/nursing notes.
Intraoperative conversion (caused by the stapler and/or cartridge)
Surgical records confirm the intraoperative conversion, and determine whether the intraoperative conversion is caused by the investigational devices according to the description.
Length of hospitalization
Records were collected for the patient's date of surgery and date of discharge . Length of hospitalization(days) = date of discharge - date of surgery
Adverse events
Common adverse events due to the device and treatment were: anastomotic leakage, bleeding, stenosis, fistula, infection, etc.
Device deficiencies
Inadequacy of medical device with respect to its identity, quality, durability, reliability, usability, safety or performance.
Serious adverse events
Incidence of serious adverse events = Number of serious adverse events/number of enrolled cases ×100%
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