MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. DISTAL ATTACHMENT

Model Number	MH-588
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Chest Pain (1776); Hemorrhage/Blood Loss/Bleeding (1888); Perforation (2001)
Type of Reportable Event	Serious Injury
Event or Problem 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 (b)(6) 2021 to (b)(6) 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: DISTAL ATTACHMENT
• Common Device Name: DISTAL ATTACHMENT
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• MDR Report Key: 18685018
• Report Number: 2429304-2024-00105
• Device Sequence Number: 7233974
• Product Code: FDS
• UDI-Device Identifier: 04953170047879
• UDI-Public: 04953170047879
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/12/2024
• Report Date (Section F): 01/18/2024

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
• Operator of Device: Health Professional
• Device Model Number: MH-588
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/12/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown