MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS LUCERA ELITE SMALL INTESTINAL VIDEOSCOPE; SMALL INTESTINAL VIDEO SCOPE

Model Number SIF-H290S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Inflammation (1932)

Event Type  Injury  

Manufacturer Narrative

The subject device was not been returned to olympus medical systems corp (omsc).Omsc could not review the service and manufacturing record because the serial number was not provided from the facility.The malfunction of the subject device concerning this case has not been reported.The exact cause could not be determined.

Event Description

Olympus medical systems corp.(omsc) received a literature title therapeutic peroral direct cholangioscopy using a single balloon enteroscope in patients with roux-en-y anastomosis (with videos).The literature reported the result of 169 cases of the peroral direct cholangioscopy (pdcs) using single-balloon enteroscope (sbe) procedures using an olympus model small intestinal video scope, sif-h290s and sif-y0015 between november, 2012 and november, 2016.In the subject procedures, 1 case of pancreatitis reportedly occurred.Based on the available information, a direct relationship between the subject devices and the observed reported adverse event could not be determined.According to the number of the accidental symptoms known and the number of olympus devices used for procedure, omsc is submitting 2 medical device reports.This is 1st of 2 reports.

• Brand Name: EVIS LUCERA ELITE SMALL INTESTINAL VIDEOSCOPE
• Type of Device: SMALL INTESTINAL VIDEO SCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 9881982
• MDR Text Key: 196474711
• Report Number: 8010047-2020-01867
• Device Sequence Number: 1
• Product Code: FDA
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: SIF-H290S
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/02/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other