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

Model Number MAJ-2315

Patient Problem Foreign Body In Patient (2687)

Event Date 12/31/2023

Event Type  malfunction  

Event 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
• Type of Device: DUODENOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): OLYMPUS AMERICA INC. / OLYMPUS MEDICAL SYSTEMS CORP.
• MDR Report Key: 18595682
• MDR Text Key: 334088703
• Report Number: MW5150818
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MAJ-2315
• Device Lot Number: H2913
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 22 YR
• Patient Sex: Female
• Patient Weight: 63 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White