MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA LLL COLONOVIDEOSCOPE; COLONOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Model Number OLYMPUS PCF-H190L

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 08/10/2022

Event Type  malfunction  

Event Description

There have been no defects or issues identified with this scope, although there have been to issues with perforations.Patient had an endoscopy procedure and during procedure spleen was injured.Will be sending scope to agility, scopes are manufactured by olympus but maintained by agility (different company).

• Brand Name: EVIS EXERA LLL COLONOVIDEOSCOPE
• Type of Device: COLONOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 800 west park drive; westborough MA 01581
• MDR Report Key: 16292938
• MDR Text Key: 308741938
• Report Number: 16292938
• Device Sequence Number: 1
• Product Code: FDF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/22/2022,12/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OLYMPUS PCF-H190L
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/22/2022
• Event Location: Other
• Date Report to Manufacturer: 02/03/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 21900 DA
• Patient Sex: Female
• Patient Race: White