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U.S. Department of Health and Human Services

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

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OLYMPUS MEDICAL SYSTEMS CORP. EVIS LUCERA SMALL INTESTINAL VIDEOSCOPE SMALL INTESTINAL VIDEOSCOPE Back to Search Results
Model Number SIF-Q260
Device Problem Insufficient Information (3190)
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 a 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 eight of nine reports.
 
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Brand NameEVIS LUCERA SMALL INTESTINAL VIDEOSCOPE
Type of DeviceSMALL INTESTINAL VIDEOSCOPE
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORP.
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8 507
JA 192-8507
Manufacturer Contact
katsuaki morita
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8-507
JA   192-8507
426425177
MDR Report Key7016824
MDR Text Key91917903
Report Number8010047-2017-01741
Device Sequence Number1
Product Code FDA
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,literatur
Reporter Occupation
Type of Report Initial
Report Date 11/10/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/10/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberSIF-Q260
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/12/2017
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 Treatment Data
Date Received: 11/10/2017 Patient Sequence Number: 1
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