SINGLE USE ELECTROSURGICAL HEMOSTATIC FORCEPS

Description of Event or Problem

OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLED ¿PULLEY TRACTION IN ENDOSCOPIC SUBMUCOSAL DISSECTION OF LESIONS IN THE UPPER TWO-THIRDS OF THE STOMACH: A RETROSPECTIVE STUDY (WITH VIDEO)¿. LITERATURE SUMMARY: BACKGROUND: ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) IN THE UPPER AND MIDDLE THIRDS OF THE STOMACH IS TECHNICALLY CHALLENGING. THERE ARE FEW REPORTS ON THE USE OF PULLEY TRACTION (PT), WHICH INVOLVES USING ORTHODONTIC RUBBER BANDS AND DENTAL FLOSS TO ASSIST WITH ESD, IN THIS AREA. WE AIMED TO EXPLORE THE EFFICACY OF PT-ESD IN THIS REGION AND COMPARE IT WITH CONVENTIONAL ESD (C-ESD). METHODS: ONE HUNDRED NINETY-SEVEN PATIENTS WHO UNDERWENT ESD FOR LESIONS LOCATED IN THE UPPER AND MIDDLE PARTS OF THE STOMACH WAS CONDUCTED. THERE WERE 40 CASES IN THE PT-ESD GROUP AND 157 IN THE C-ESD GROUP. THE PRIMARY OUTCOME MEASURE WAS DISSECTION SPEED. RESULTS: PRIOR TO PROPENSITY SCORE MATCHING (PSM), THE LESION SIZE AND SPECIMEN DIAMETER WERE LARGER IN THE PT-ESD GROUP THAN IN THE C-ESD GROUP. THE PT-ESD GROUP ALSO EXPERIENCED A LONGER PROCEDURE TIME (78.5 ± 28.7 VS. 64.9 ± 44.0 MIN, P = 0.02). HOWEVER, THE PT-ESD GROUP HAD A SIGNIFICANTLY FASTER DISSECTION SPEED (20.8 [IQR, 16.4, 30.6] VS. 9.4 [IQR, 6.0, 13.1] MM2/MIN, P < 0.001). THERE WERE NO STATISTICALLY SIGNIFICANT DIFFERENCES IN EN BLOC RESECTION, R0 RESECTION RATE, ADVERSE EVENTS OR PATHOLOGICAL RESULTS. PSM MATCHED 30 PAIRS OF PATIENTS. ALTHOUGH THE LONG DIAMETER OF THE SPECIMENS IN THE PTESD GROUP WAS LARGER, THE PROCEDURE TIME FOR BOTH GROUPS WAS COMPARABLE, AND THE DISSECTION SPEED OF THE PT-ESD GROUP REMAINED FASTER (P < 0.001). ACCORDING TO TABLE 2, 10 PATIENTS HAD MUSCLE INJURY; 6 HAD DELAYED BLEEDING; 3 HAD PERFORATION; AND 8 HAD ABDOMINAL PAIN. CONCLUSIONS: THE STUDIED PULLEY TRACTION METHOD DEMONSTRATED A GOOD DISSECTION SPEED AND AN ACCEPTABLE COMPLICATION RATE FOR LESIONS IN THE UPPER AND MIDDLE THIRDS OF THE STOMACH. IT IS A FEASIBLE AND SAFE TRACTION METHOD. TYPE OF SERIOUS ADVERSE EVENTS/NUMBER OF PATIENTS: DELAYED BLEEDING (HEMOGLOBIN DECREASED BY = 20 G/L WITHIN 30 DAYS POST-SURGERY WITH HEMATEMESIS OR MELENA, REQUIRING BLOOD TRANSFUSION OR ENDOSCOPIC INTERVENTION) - 6 PATIENTS PERFORATION (EXPOSURE OF ABDOMINAL CAVITY TISSUES DURING THE PROCEDURE OR FREE GAS IN THE ABDOMINAL CAVITY ON POSTOPERATIVE IMAGING) - 3 PATIENTS. THIS EVENT INCLUDES 4 REPORTS. THIS REPORT IS 4 OF 4.

Additional Manufacturer Narrative

E1: INITIAL REPORTER ESTABLISHMENT NAME: (B)(6) DEPARTMENT OF GASTROENTEROLOGY. SINCE THE LITERATURE DESCRIBED ""COAGRASPER"", OLYMPUS SELECTED FD-410LR AS A REPRESENTATIVE PRODUCT. THE DEVICE HAS NOT BEEN RETURNED TO OLYMPUS FOR EVALUATION. BASED ON THE RESULTS OF THE INVESTIGATION, THE RELATIONSHIP BETWEEN THE DEVICE AND THE ADVERSE EVENT CANNOT BE CONFIRMED. THERE IS NO EVIDENCE OF AN OLYMPUS DEVICE MALFUNCTION. THEREFORE, THE ROOT CAUSE CANNOT BE DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.