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

Model Number SIF-H290S

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Inflammation (1932); Not Applicable (3189)

Event Type  Injury  

Manufacturer Narrative

The subject device has 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.There was no malfunction report of the subject device associated with these events.The exact cause could not be determined.

Event Description

On october 12, 2017, olympus medical systems corp received a literature titled ¿study on related treatments using short single balloon endoscope (sbe) in endoscopic retrograde cholangiography (ercp) for patients who experienced intestinal reconstructive surgery: our experience¿.The literature reported the result of a comparative study on procedure groups: group a where endoscopic treatments were (15 procedures in 10 cases) performed to the post-operative biliopancreatic duct using short sbe (olympus sif-h290s) from july 2014 to february 2017, and group b where similar surgeries were (43 procedures in 28 cases) performed using existing single balloon endoscope (olympus, sif-q260) from april 2014 to june 2016.The operative methods of reconstruction intended by the endoscopic treatment are as follows.Group a: roux-en-y reconstruction after gastrectomy (7 procedures, 46.7%), billroth ii after gastrectomy (1 procedure, 6.7%) and roux-en-y reconstruction after choledochojejunostomy (7 procedures, 46.7%); group b: roux-en-y reconstruction after gastrectomy (21 procedures, 48.8%), billroth ii after gastrectomy (4 procedure, 8.3%) roux-en-y reconstruction after choledochojejunostomy (18 procedures, 41.9%).Two procedures in group b where sif-h290s failed to access to the target site were completed with sif-q260.In addition, the literature reported some accidental disease in group a and group b; group a includes 1 procedure of hyperamylasemia and 1 procedure of cholangitis.Group b includes 2 procedures of minor acute pancreatitis, 2 procedures of hyperamylasemia and 1 procedure of aspiration pneumonia.The literature concluded as ¿short sbe is considered to contribute to reduction of total surgical time by providing greater choice of surgical accessory in spite of some procedures where short sbe had a difficulty in accessing to the target site¿ olympus is submitting nine reports because the sif-h290s was used in the two accidental disease (group a) cases and sif-q260 was possibly used in the seven accidental disease cases (group a and group b).This report is one of nine reports.

Manufacturer Narrative

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

• Brand Name: EVIS LUCERA ELITE SMALL INTESTINALVIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to
• Manufacturer Contact: katsuaki morita ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 7016523
• MDR Text Key: 91918532
• Report Number: 8010047-2017-01705
• Device Sequence Number: 1
• Product Code: FDA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• 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: 11/09/2017
• 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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/20/2019
• 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