MAUDE Adverse Event Report: OLYMPUS OLYMPUS TJF 180V

Model Number TJF 180V

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 10/02/2017

Event Type  Injury  

Event Description

During ercp using an olympus tjf180v scope, a small green item was seen in the pt's duodenum.No small green devices were used during the procedure.Concern that possibly a pancreatic stent was stuck in the suction/introduction channel of scope, and was not removed during the multiple manual and automated cleanings.

• Brand Name: OLYMPUS TJF 180V
• Type of Device: OLYMPUS TJF 180V
• Manufacturer (Section D): OLYMPUS; center valley PA 18034
• MDR Report Key: 6922054
• MDR Text Key: 88819952
• Report Number: MW5072627
• 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: Nurse
• Type of Report: Initial
• Report Date: 10/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TJF 180V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2017
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 92 YR