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

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 titled ¿the usefulness of endoscopic treatment for intrahepatic stone disease¿.The literature reported the result of 57 cases of the treatment for intrahepatic calculosis procedures between 2003 and 2018.There was a possibility that sbe-ercp (single balloon enteroscopy - endoscopic retrograde cholangiopancreatography) was performed using the sif-h290s.In this literature, it was reported adverse events as follows after the procedures; cholangitis occurred in 3 cases.Recurrence of intrahepatic stone disease occurred in 4 cases.Liver abscess occurred in 1 case.Bile duct cancer occurred in 1 case.Based on the available information, a direct relationship between the subject device and the reported adverse events could not be determined.Omsc is submitting nine mdrs according to the number of the adverse events.This is 2 of 9 reports.(2 of 3 cholangitis cases).

• 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: 9494297
• MDR Text Key: 188806997
• Report Number: 8010047-2019-04429
• 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: 12/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2019
• 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: 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