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

Model Number MAJ-2315

Device Problems Component Missing (2306); Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/14/2023

Event Type  malfunction  

Event 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scope entered the intestines via laparoscopy trocar.It is believed that the cap came off as the scope was being withdrawn through the trocar.(trocar was 15mm, scope was 13.5mm.) after the scope was fully withdrawn, staff observed that the cap was missing from scope and began search.Bowel loops were searched, along with surgical drapes and floor.X-ray prior to case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
• Type of Device: ENDOSCOPE, ACCESSORIES, NARROW BAND SPECTRUM
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.
• MDR Report Key: 16796905
• MDR Text Key: 313926224
• Report Number: MW5116931
• Device Sequence Number: 1
• Product Code: NWB
• 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: 04/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2023
• 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: H2613
• 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
• Treatment: OLYMPUS ERCP SCOPE
• Patient Outcome(s): Other
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White