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).This report is related to patient identifier (b)(6).

• 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
• MDR Report Key: 18684794
• MDR Text Key: 335198419
• Report Number: 2429304-2024-00104
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/18/2024,02/12/2024

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?: Yes
• Distributor Facility Aware Date: 01/18/2024
• Event Location: Hospital
• Date Report to Manufacturer: 01/18/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization