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

Model Number GIF-H180

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

Patient Problem Injury (2348)

Event Type  Injury  

Manufacturer Narrative

As no serial numbers were provided for the scope olympus was unable to determine if the scope was returned for evaluation or complete a device history record review.Therefore, the exact cause of the user's experience and the reported phenomenon could not be determined.Farias, g., de moura, d., de moura, e.T.H., de rezende, d., hathorn, k., nasi, a.De moura, e.G.H.(2020) peroral endoscopic myotomy (poem): a comparative study between chagasic and idiopathic achalasia.Endoscopy international open, (b)(4).(b)(4).

Event Description

Olympus medical systems corporation (omsc) received a journal article titled "peroral endoscopic myotomy (poem): a comparative study between chagasic and idiopathic achalasia." the aim of the study was to compare the efficacy and safety of poem in patients with chagasic achalasia compared to idiopathic achalasia.The study concluded that poem is an effective and safe treatment for patients with achalasia and there was no difference in poem outcomes for those patients with chagasic or idiopathic achalasia.The study identified 10 adverse events that occurred in patients.This report is for a patient with an gastric mucosal injury which was successfully treated with a hemoclip placement.This complaint will capture # 2 of 10 adverse events.

Manufacturer Narrative

This report is being supplemented to provide the legal manufacturer¿s investigation summary regarding this report and more information about the reported adverse events from the literature.The legal manufacturer further reviewed the literature and since there were no reported defects or malfunction on the olympus¿ devices and alleged that the cause of the reported adverse events was not due to product defects, but cannot conclusively determined the cause of the patients¿ outcome.Olympus followed up with the authoring physician in an attempt to obtain additional information, and if additional information becomes available at a later time, this report will be updated accordingly.Cross-referenced the following related reports: 8010047 - 2020 ¿ 02725, 8010047 - 2020 ¿ 02727, 8010047 - 2020 ¿ 02728, 8010047 - 2020 ¿ 02729, 8010047 - 2020 ¿ 02730, 8010047 - 2020 ¿ 02731, 8010047 - 2020 ¿ 02732, 8010047 - 2020 ¿ 02733, 8010047 - 2020 ¿ 02734.

Event Description

The article reported the following adverse events from each type of procedures and they are as follows: in the chagasic group there were total of six adverse events; three are gastric mucosal injury and two were esophageal mucosal injury; and one patient was reported to have experienced a pulmonary thromboembolism.In the idiopathic group there were four adverse events reported; there were two patients that experienced a gastric mucosal injury and two patients that experienced an esophageal mucosal injury.

• Brand Name: EVIS EXERA II 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: 10061584
• MDR Text Key: 199902535
• Report Number: 8010047-2020-02726
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04953170202285
• UDI-Public: 04953170202285
• Combination Product (y/n): N
• PMA/PMN Number: K100584
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 10/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: GIF-H180
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OLYMPUS UCR CO2 INSUFFLATOR
• Patient Outcome(s): Required Intervention