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

Model Number GIF-H190

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Chest Pain (1776); Fever (1858); Organ Dehiscence (2502)

Event Type  Injury  

Manufacturer Narrative

This report is being submitted report the user's experience and the investigation findings.The device history record (dhr) for the complaint devices could not be reviewed since the serial numbers were not provided.Olympus does not ship any device that does not meet all design and safety specifications conclusion: no malfunction of an olympus device was reported during any procedure described in this study.The definitive cause of the patient's adverse event cannot be established, however, based on the information reported in the article is not likely due to the device this event has been reported by the importer on mfr report # 2951238-2021-00301.

Event Description

It is reported the literature article titled "safety and feasibility of performing peroral endoscopic myotomy as an outpatient procedure with same-day discharge", one patient experienced a moderate adverse event requiring hospitalization and surgical intervention.This is a single center retrospective study of 103 consecutive outpatient peroral endoscopic myotomy (poem) procedures performed from january 2015 to december 2018 by one of two physicians using an evis exera iii gastrointestinal videoscope fitted with a transparent cap.The aim of the study is to describe an algorithm and safety feasibility for same-day discharge following poem procedure.It is reported there were no serious adverse events (ae) or fatalities in this cohort of patients.There were 11(10.7%) with mild to moderate aes reported.This report describes the one patient who was re-admitted for post-procedural chest pain, low-grade fever, and persistently increased white blood cell (wbc) count who underwent an esophagram showing a dehiscence with leak at the mucosal entry site.This patient required a second look endoscopic procedure and endoscopic clipping of the dehiscence.There is no report of any olympus device malfunction in any of the reported procedures.

• 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 11574122
• MDR Text Key: 242399097
• Report Number: 8010047-2021-04187
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04953170305290
• UDI-Public: 04953170305290
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131780
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: GIF-H190
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/07/2021
• Initial Date FDA Received: 03/26/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention