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

Model Number	D-201-11804
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported, the disposable distal attachment (cap) fell off from the gastrointestinal videoscope and into the patient's stomach in the middle of a therapeutic esophagogastroduodenoscopy with food bolus disimpaction and was retrieved by the physician.The procedure and patient's anesthesia were prolonged for about 30 minutes and was completed with a different scope and cap.The patient was intubated prior to the procedure due to aspiration risk and was extubated the next day.Reportedly, the plan would most likely have been the same even if the cap had not fallen off due to the large amount of retained food.The customer confirmed that the condition of the patient and outcome of the procedure was not impacted.Both devices were inspected prior to use and the staff had made sure that the scope was compatible with the cap.The patient was discharged to home without any further harm.

• Brand Name: DISPOSABLE DISTAL ATTACHMENT
• Common Device Name: DISPOSABLE 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: 19249279
• Report Number: 2429304-2024-00235
• Device Sequence Number: 15286938
• Product Code: FDS
• UDI-Device Identifier: 04953170453854
• UDI-Public: 04953170453854
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/06/2024
• Report Date (Section F): 04/26/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: D-201-11804
• Device Lot Number: 3ZK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/26/2024
• Event Location: Hospital
• Date Report to Manufacturer: 04/26/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/06/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GASTROINTESTINAL VIDEOSCOPE (GIF-HQ190/2167610)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 31 YR
• Patient Sex: Male
• Patient Weight: 60 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White