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

Lot Number H3307

Patient Problems Hemorrhage/Bleeding (1888); Laceration(s) of Esophagus (2398)

Event Date 12/28/2023

Event Type  Injury  

Event 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)
• Type of Device: DUODENOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.
• MDR Report Key: 18483493
• MDR Text Key: 332613286
• Report Number: MW5150041
• 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: 01/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: H3307
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Hospitalization; Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White