MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA II DUODENOVIDEOSCOPE; ENDOSCOPE, ACCESSORIES, NARROW BAND SPECTRUM

Model Number TJF-Q180V

Device Problems Suction Problem (2170); Failure to Advance (2524); Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 11/07/2021

Event Type  malfunction  

Event Description

Elderly male while undergoing an ercp (endoscopic retrograde cholangiopancreatography) procedure using olympus scope, the gi (gastrointestinal) doctor tried to insert the sphincterotome in the scope however the sphincterotome would not go through the scope.We had to stop using the scope and replace with a disposable ercp scope.The case was performed successfully without incident.Following the procedure, while cleaning the scope, we could not suction water at the distal end, nor put a brush through the scope.The scope was leak tested and no leak was found.Attempts to clean the scope were made; however we could not suction asepti-zyme or water through the distal end of the scope.We could suction aspti-zyme and water through the biopsy channel and water port.We wiped down the scope with asepit-zyme and water and then wiped it down with water.I placed it in a biohazard bag.The scope was sent out for repair the next day.The results are not yet known.Manufacturer response for endoscope, endoscope (per site reporter).The manufacturer was indirectly notified via the vendor who handles repairs.The equipment has not yet been returned.

• Brand Name: EVIS EXERA II DUODENOVIDEOSCOPE
• Type of Device: ENDOSCOPE, ACCESSORIES, NARROW BAND SPECTRUM
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2400 ringwood ave; san jose CA 95131
• MDR Report Key: 12860158
• MDR Text Key: 281155605
• Report Number: 12860158
• Device Sequence Number: 1
• Product Code: NWB
• 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: 11/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TJF-Q180V
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/15/2021
• Event Location: Hospital
• Date Report to Manufacturer: 11/23/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 27010 DA
• Patient Sex: Male
• Patient Weight: 64 KG
• Patient Race: White