MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS LUCERA DUODENOVIDEOSCOPE

Model Number TJF-260V

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/10/2018

Event Type  malfunction  

Manufacturer Narrative

The subject device in this report was returned to omsc for evaluation.The evaluation is still in progress.Omsc reviewed the manufacture history of the subject device and confirmed no irregularity.The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) was informed that during a procedure, a pancreatic stent was expelled from the subject device when the user inserted a 7 fr.Biliary stent into the device.The user reported that the pancreatic duct stent had not been used at the user facility and the subject device was a loaner device from olympus.It was second procedure for the user facility that the subject device was used at the facility, and the first procedure was a cholangiography using an endoscopic retrograde cholangiography (ercp) catheter.After the first procedure, the subject device was manually cleaned and reprocessed with an olympus automated endoscope reprocessor model oer-4 (not available in the usa).When the user retrieved the pancreatic duct stent from the subject device and inspected it, the facility found that the stent was partially damaged.Therefore, the user facility believed that a part of the stent possibly fell off and remained in the patient.There was no report of patient injury with this report.

Manufacturer Narrative

This supplemental report is submitting to correct "device product code".

• Brand Name: EVIS LUCERA DUODENOVIDEOSCOPE
• Type of Device: DUODENOVIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to
• MDR Report Key: 8049853
• MDR Text Key: 128744037
• Report Number: 8010047-2018-02139
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,user facility
• Type of Report: Initial,Followup
• Report Date: 02/22/2019

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-260V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/11/2018
• Initial Date FDA Received: 11/08/2018
• Supplement Dates Manufacturer Received: 02/13/2019
• Supplement Dates FDA Received: 02/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1