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 Problem Injury (2348)

Event Type  Injury  

Manufacturer Narrative

The subject device has not been returned to olympus medical systems corp (omsc) for evaluation.Omsc could not review the service and manufacturing record (dhr) because the serial number was not described on the literatures.There was no malfunction report of the subject device concerning the events.The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available, this report will be supplemented.

Event Description

On may 31st, 2019, olympus medical systems corp.(omsc) received a literature titled ¿endoscopic radiofrequency ablation combined with metal stent placement for malignant biliary obstruction in patients with surgically altered anatomy¿ that was made in public in the 97th congress of the japan gastroenterological endoscopy society.The literature reported the result of sixteen cases of the metal stent placement with radiofrequency ablation for unresected malignant biliary stricture among cases in which endoscopic retrograde cholangiography using an olympus small intestinal videoscope (sif-h290s) between 2017 and 2018.A non-olympus catheter (emcision) and a non-olympus electrosurgical unit (erbe) were used for radiofrequency ablation.In the subject procedures, one case of mild pancreatitis and one case of hepatic abscess reportedly occurred.The presentor commented that no serious accidental symptoms such as bleeding occurred.Based on the available information, a direct relationship between the olympus small intestinal videoscope (sif-h290s) and the observed adverse events could not be determined.Therefore, according to the number of the accidental symptoms known and the number of olympus device used for procedure, omsc is submitting two medical device reports.This is a report on mild pancreatitis and one of two reports.

• 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: 8730325
• MDR Text Key: 149077075
• Report Number: 8010047-2019-02280
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2019
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other