Olympus was notified of the following literature article, endoscopic mucosal incision and muscle interruption (mimi) for the treatment of zenker¿s diverticulum (zd).All patients with zd who were treated by flexible endoscopy at our institution between january 2015 and february 2020 were identified by a retrospective chart review.Dysphagia symptoms were assessed using a validated scoring system.Nineteen patients with zd underwent mimi (mean age 76.1 years, 68.1% male) and seven patients underwent non-tunneled flexible endoscopic approach (mean age 64.4 years, 85.7% male) during the study period.The authors concluded mimi is a technically feasible and effective treatment for zd.Care should be taken in patients with a cricopharyngeal bar and small zd, as this may increase the risk of perforation.Larger studies with long-term follow-up are needed to determine if mimi reduces the risk of symptom recurrence when compared to non-tunneled flexible endoscopic approaches.All cases were performed using the olympus gif-hq190 with a non-olympus beveled silicone-based endoscopic cap.The vertical incisions were made with the triangle tip olympus kd-640l on cutting current (effect 2-1-2) and a non-olympus electrosurgical generator.The following adverse events were reported: mimi group: 1 severe perforation requiring open surgical repair and with retropharyngeal abscess formation and mediastinitis necessitating transcervical washout and pharyngeal repair.Non-tunneled flexible endoscopic approach group: 1 moderate contained perforation, treated non-operatively with short course of oral antibiotics.1 readmission with moderate neck crepitus, treated conservatively.Patient identifier (b)(6) is for gif-hq190 and the reported adverse events.Patient identifier (b)(6) is for kd-640l and the reported adverse events.This report is for 2 of 2 for patient identifier (b)(6) is for kd-640l and the reported adverse events.
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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 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.Olympus will continue to monitor field performance for this device.
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