MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS LUCERA ELITE SMALL INTESTINALVIDEOSCOPE

Model Number SIF-H290S

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

Patient Problems Death (1802); Internal Organ Perforation (1987); Perforation of Esophagus (2399)

Event Date 09/25/2018

Event Type  Death  

Manufacturer Narrative

The subject device has not been returned to omsc.Omsc reviewed the manufacturing history of the sif-h290s and confirmed no irregularity.The exact cause could not be determined.The instruction of the subject device already warns;¿ when using the endoscope, make appropriate judgments and treatments from trained specialist viewpoints to avoid complications such as bleeding, perforation, or pancreatitis.A medical literature reports that the incidence of complications such as gastrointestinal perforation is 5¿10% when using an endoscope for a patient with altered anatomy.If any complication is observed, immediately stop the endoscopy/treatment and take proper measures.¿.

Event Description

Olympus medical systems corp.(omsc) was informed that during an endoscopic retrograde cholangiography (ercp) for a patient, who had experienced intestinal reconstructive surgery, the duodenum and the esophagus of the patient were perforated and the patient died several days after the ercp procedure.It was also reported that olympus sliding tube (st-sb1s) and sigmoid videoscope (sif-h290s) were used in the ercp procedure.Olympus followed up with the user facility to obtain additional information, but the user facility denied providing detailed further information on the event.In addition, there was no request from the user facility to olympus.

Manufacturer Narrative

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

• Brand Name: EVIS LUCERA ELITE SMALL INTESTINALVIDEOSCOPE
• Type of Device: SMALL INTESTINALVIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to
• MDR Report Key: 8022910
• MDR Text Key: 125593026
• Report Number: 8010047-2018-02096
• Device Sequence Number: 1
• Product Code: FDA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 03/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SIF-H290S
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death