MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. 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); Hemorrhage/Bleeding (1888); Perforation (2001)

Event Type  Injury  

Event Description

Olympus medical systems corporation reviewed a literature titled "short-term outcome of peroral endoscopic myotomy performed by the same endoscopist on achalasia and nonachalasia esophageal motility disorders." a retrospective analysis of all patients undergoing poem at one university hospital by a single expert endoscopist from july 2021 to december 2022 was performed.All patients were symptomatic, and the presence of esophageal motility disorders was confirmed using multiple diagnostic modalities.These patients were then divided into 2 groups, achalasia and naemd, based on the underlying diagnosis.Statistical analysis of different clinical outcomes, including effectiveness and safety, was performed.Adverse events/number of patients: chest pain (3).Blood loss (1).Perforation (1).Two patients in the achalasia group experienced moderate blood loss during the procedure but did not develop hemodynamic instability or require blood transfusion.One patient in the achalasia group and 2 patients in the naemd group reported severe chest pain immediately after the procedure.These patients were admitted under close observation and pain was controlled with intravenous opioids and ppi, and patients were subsequently discharged.One patient in the naemd group had an esophageal mucosal injury requiring closure with one endoscopic clip.This patient did not require hospital admission or additional treatment.In total, 9 patients from the achalasia group and 10 patients from the naemd group were admitted to the hospital post procedure with the mean hospital stay being 1.2 and 0.82 days, respectively, for each group.As previously mentioned, patients were admitted post procedurally for both clinical reasons (pain, procedure difficulty, and complications and social factors (patient preference, travel distance, and ride availability).

Manufacturer Narrative

This report is related to patient identifier (b)(6).This report has been submitted by the importer under this mdr report number (b)(4).The literature article is attached for additional information.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and to provide additional information received through follow up.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 events 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.Olympus will continue to monitor field performance for this device.

Event Description

The author does not believe that an olympus device malfunctioned during any case.The chest discomfort was uncomplicated procedures, only subcutaneous emphysema was the fault of tech who used air instead of co2.

• Brand Name: EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
• Type of Device: GASTROINTESTINAL VIDEOSCOPE
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer (Section G): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18684839
• MDR Text Key: 335116532
• Report Number: 9610595-2024-02910
• Device Sequence Number: 1
• Product Code: FDS
• 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: Study,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2024
• 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
• Date Manufacturer Received: 02/22/2024
• 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): Required Intervention; Hospitalization