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U.S. Department of Health and Human Services

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

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OLYMPUS MEDICAL SYSTEMS CORP. OLYMPUS DISTAL COVER - ERCP SCOPE (190); DUODENOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID Back to Search Results
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.
 
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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 Key18483493
MDR Text Key332613286
Report NumberMW5150041
Device Sequence Number1
Product Code FDT
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Lot NumberH3307
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received01/09/2024
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other; Hospitalization; Required Intervention;
Patient Age75 YR
Patient SexMale
Patient EthnicityNon Hispanic
Patient RaceWhite
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