MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. OLYMPUS DISTAL COVER - ERCP SCOPE (190); DUODENOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Lot Number	H3307
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Laceration(s) of Esophagus (2398)
Date of Event	12/28/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Pt was undergoing ercp, difficult scope intubation with bleeding noted.Removed ercp scope and used egd scope to evaluate.Tear in upper esophagus noted and believed to be caused by disposable distal cap cover on olympus 190 scope.

• Brand Name: OLYMPUS DISTAL COVER - ERCP SCOPE (190)
• Common Device Name: DUODENOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.
• MDR Report Key: 18483493
• Report Number: MW5150041
• Device Sequence Number: 3550261
• Product Code: FDT
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 01/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Lot Number: H3307
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/09/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Hospitalization; Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White