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

Model Number SIF-Q260

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.As part of our investigation, omsc reviewed all of the complaints for the period, but there was no record associated with the event described in the article.The exact cause of the reported event could not be conclusively determined.

Event Description

Olympus medical systems corp.(omsc) was received jddw (japan digestive disease week) literature abstract that stated the result of the endoscopic treatment for bile duct stones using with sbe-ercp (endoscopic retrograde cholangiopancreatography using with single balloon endoscope) and ultrasound endoscope to the patients whom had experienced intestinal reconstructive surgery.The literature abstract reported the result of the ercp procedures for bile duct stones in 117 cases from april 2011 to march 2019.As accidental symptoms, the pancreatitis occurred in 5 cases after the ercp procedures, the small perforation occurred in 1 case during the pre-cut.The each patients were treated conservatively.The intestinal perforation occurred in 2 cases and it required the open abdominal surgery.Based on the available information, a direct relationship between the olympus product and the observed adverse events could not be determined.Omsc is submitting mdr according to the number of types of the accidental symptom.This is 4 of 8 reports.(4 of 5 pancreatitis cases).

• Brand Name: EVIS LUCERA SMALL INTESTINAL VIDEOSCOPE
• Type of Device: SMALL INTESTINAL VIDEOSCOPE
• 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: 9462807
• MDR Text Key: 185200489
• Report Number: 8010047-2019-04293
• 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,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Model Number: SIF-Q260
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/21/2019
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other