MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE

Model Number GIF-HQ190

Device Problem Use of Device Problem (1670)

Patient Problems Abscess (1690); Laceration(s) (1946); Perforation of Esophagus (2399); Swelling/ Edema (4577)

Event Date 08/06/2020

Event Type  Injury  

Event Description

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 1 of 2 for patient identifier (b)(6): gif-hq190 and the reported adverse events.

• Brand Name: EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
• Type of Device: GASTROINTESTINAL VIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 12961745
• MDR Text Key: 281933005
• Report Number: 2951238-2021-00444
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04953170305276
• UDI-Public: 04953170305276
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/08/2021,12/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: GIF-HQ190
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/08/2021
• Event Location: Hospital
• Date Report to Manufacturer: 11/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: KD-640L, UNKNOWN LOT
• Patient Outcome(s): Required Intervention; Hospitalization; Other