Olympus reviewed the following literature titled "efficacy and safety of clearcut¿ knife h-type in endoscopic submucosal dissection for gastric neoplasms: a multicenter, randomized trial." literature summary: this randomized, controlled trial aimed to evaluate the efficacy and safety of the clearcut¿ knife h-type, which is an integrated needle-tipped and insulated-tipped (it) knife.A total of 98 patients (50 in the h-knife group and 48 in the it-knife group) were analyzed.The median total procedure time was 11.9 minutes (range, 4.4¿47.2 minutes) in the h-knife group and 12.7 minutes (range, 5.2¿137.7 minutes) in the it-knife group (p=0.209).The complete resection rates in the h-knife and it-knife groups were 97.9% and 95.8%, respectively (p>0.999).The curative resection rate was lower in the h-knife group than in the it-knife group (89.4% vs.93.8%, p=0.486).The overall adverse event rates were not significantly different between the 2 groups (p=0.431).The newly developed hybrid device, the clearcut¿ knife h-type, had comparable efficacy to the conventional it knife for gastric esd.Type of adverse events/number of patients gif-q260j, gif-hq290: *early delayed bleeding(4) , *microperforation(2) , itknife2, dual knife: *early delayed bleeding(4) microperforation was defined as minimal free air on chest radiography without symptoms or signs of peritonitis.Microperforation occurred in 2 patients (4.0%) in the h-knife group.The patients with microperforations were treated conservatively without additional interventions.Early delayed bleeding was confirmed in 4 patients in the it-knife group (8.3%) and required additional hemostasis and an extension to the hospitalization period.There is no report of any olympus device malfunction in any procedure described in this study.This literature requires 4 reports.The related patient identifiers are as follows: (b)(6) :gif-q260j, (b)(6) :gif-hq290, (b)(6) :kd-611l & (b)(6) :kd-650l.This report is for (b)(6).
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This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device history record was unable to be reviewed for this device since the serial and/or lot number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, the relationship between the device and the adverse event cannot be confirmed.There was no complaint reported on the subject device.There is no evidence of an olympus device malfunction.Therefore, the root cause cannot be determined.Olympus will continue to monitor field performance for this device.
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