MAUDE Adverse Event Report: OLYMPUS AMERICA INC. / OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA III DUODENOVIDEOSCOPE; DUODENOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Model Number	MAJ-2315
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/31/2023
Type of Reportable Event	Malfunction
Event or Problem Description
When they took the duodenoscope out, they saw the cap was not attached, and went back in to attempt to retrieve it.It was too far down into the small bowel to be retrieved; therefore it was left in place to be "passed through the patient's stool." the patient was notified after the fact to watch for it.If she cannot identify it, then she will return for a ct scan to ensure it has passed through.

• Brand Name: EVIS EXERA III DUODENOVIDEOSCOPE
• Common Device Name: DUODENOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): OLYMPUS AMERICA INC. / OLYMPUS MEDICAL SYSTEMS CORP.
• MDR Report Key: 18595682
• Report Number: MW5150818
• Device Sequence Number: 7119011
• Product Code: FDT
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 01/24/2024

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
• Operator of Device: Health Professional
• Device Model Number: MAJ-2315
• Device Lot Number: H2913
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/26/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 22 YR
• Patient Sex: Female
• Patient Weight: 63 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White