MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. DISPOSABLE DISTAL ATTACHMENT; GASTROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Model Number	D-201-11804
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
While egd scope inserted into patient esophagus, distal attachment became detached and came off end of scope.Distal attachment retrieved and intact at 1021.Management aware.

• Brand Name: DISPOSABLE DISTAL ATTACHMENT
• Common Device Name: GASTROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 800 west park drive; westborough MA 01581
• MDR Report Key: 20245650
• Report Number: 20245650
• Device Sequence Number: 7397843
• Product Code: FDS
• UDI-Device Identifier: 04953170278280
• UDI-Public: (01)04953170278280
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 06/05/2024
• Report Date (Section F): 06/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: D-201-11804
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 09/18/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/18/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 83 YR
• Patient Sex: Female
• Patient Weight: 67 KG
• Date Report Sent to FDA: 06/05/2024