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

Model Number UNKNOWN

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

Patient Problem Perforation (2001)

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 titled ¿study on bowel endoscopic ercp (be-ercp) using small intestinal scope in the bile duct stone for the elderly patients who experienced intestinal reconstructive surgery¿ that was made in public in 26th japan digestive disease week (jddw).The literature reported the result of the be-ercp procedures for bile duct stones in 189 cases for the elderly patients and the procedures were conducted between november 2008 and january 2018 at user facility.In the procedures, pancreatitis (1.2%: over 75 years, 1.9%: under 75 years), perforation (4.7%: over 75 years, 3.8%: under 75 years), bleeding (1.2%: over 75 years, 1.9%: under 75 years) and respiratory failure (0%: over 75 years, 1.0%: under 75 years) as accidental symptom reportedly occurred.In the jddw, it was also reported that olympus small intestinal videoscope model sif-q260 or sif-h290s were used in the procedures.Omsc tried to obtain detailed information, but additional information was not obtained.Omsc is submitting mdr according to the number of types of the accidental symptom.This is 2 of 4 reports.

• Brand Name: EVIS LUCERA ELITE SMALL INTESTINALVIDEOSCOPE
• 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: 8118696
• MDR Text Key: 128861567
• Report Number: 8010047-2018-02329
• 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: 11/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/02/2018
• 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