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 Inflammation (1932); Injury (2348)

Event Type  Injury  

Manufacturer Narrative

The subject devices have not been returned to omsc.Omsc could not review service and manufacturing records because the serial numbers of the subject devices were 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) received a literature titled ¿initial results of introduction of short type balloon endoscope for postoperative reconstruction ercp case in our hospital¿.The literature reported the result of 8 cases of the endoscopic retrograde cholangiopancreatography (ercp) procedures for patients with postoperative intestinal reconstruction using olympus small intestinal videoscope model sif-h290s.In the subject cases, 3 cases of pancreatitis and 3 cases of hyperamylasemia occurred.Based on the available information, a direct relationship between the olympus product and the observed adverse events could not be determined.Omsc is submitting three mdrs according to the number of the complication case.This report is the 3rd of 3 cases and corresponds to hyperamylasemia.

• 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 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: 8726626
• MDR Text Key: 148923715
• Report Number: 8010047-2019-02270
• 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,study,user facilit
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2019
• 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: 05/31/2019
• 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: Reuse
• Patient Sequence Number: 1