Olympus reviewed the following literature article: "efficacy and safety of endoscopic submucosal tunnel dissection for rectal laterally spreading tumors" by enqiang linghu et al. this study was aimed to evaluate the efficacy and safety of endoscopic submucosal tunnel dissection (estd) for colorectal laterally spreading tumors (lsts) compared with standard endoscopic submucosal dissection (esd).A total of 143 patients were included in the study who had undergone either esd (n = 84) or estd (n = 59) and were assessed for performance and safety outcomes.The study reported that en bloc resection and r0 resection were achieved in 135 lesions (94.4%) and 130 lesions (90.9%), respectively, and a median dissection speed reported was 24.53 mm2/min.The intraoperative adverse events rate was 3.4%.In conclusion, the study supported estd as it appeared to be a safe and effective method to treat rectal lsts.When compared with esd, estd also had a higher dissection speed.Events: intraoperative muscular damage (n=7) with perforations (n=4) treated with local closure, fasting, and broad-spectrum antibiotics.Delayed bleeding (n=3): treated by endoscopic clipping and electronic coagulation. the authors used 4 different olympus devices in the procedures and reported intraoperative muscular damage, perforation, delayed bleeding and local recurrence @ follow up.The authors did not specify the devices used on the patients with adverse events.Therefore all will be reported as follows: patient identifier (b)(6)- d-201-11804.Patient identifier (b)(6)- fd-410lr.Patient identifier (b)(6)- kd-650u.Patient identifier (b)(6)- gif-q260j.This report is 2 of 4 for patient identifier (b)(6)- fd-410lr.
|
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.Required follow up attempts to obtain additional details about the event were completed; however, no new information was received from the customer.Olympus will continue to monitor field performance for this device.
|