MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. OLYMPUS SINGLE USE DISTAL COVER; ENDOSCOPE, ACCESSORIES, NARROW BAND SPECTRUM

Model Number	MAJ-2315
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Ercp scope cap apparently came off during ercp procedure.The scope entered the intestines via laparoscopy trocar.It is believed that the cap came off as the scope was being withdrawn through the trocar.(trocar was 15mm, scope was 13.5mm.) after the scope was fully withdrawn, staff observed that the cap was missing from scope and began search.Bowel loops were searched, along with surgical drapes and floor.X-ray prior to case closure not possible because the cap is not radiopaque.Ct-abdomen-pelvis performed the next day did not show a cap.It is believed that the cap was left in the gi tract and will pass spontaneously.It is our suggestion that this cap include a radiopaque marker.

• Brand Name: OLYMPUS SINGLE USE DISTAL COVER
• Common Device Name: ENDOSCOPE, ACCESSORIES, NARROW BAND SPECTRUM
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.
• MDR Report Key: 16796905
• Report Number: MW5116931
• Device Sequence Number: 7065470
• Product Code: NWB
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 04/19/2023

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 Expiration Date: 05/31/2025
• Device Model Number: MAJ-2315
• Device Lot Number: H2613
• 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: 04/21/2023
• 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: OLYMPUS ERCP SCOPE
• Outcome Attributed to Adverse Event: Other
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White