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

Model Number UNKNOWN

Device Problem Insufficient Information (3190)

Patient Problem Perforation (2001)

Event Type  Injury  

Manufacturer Narrative

The subject device was not returned to olympus medical systems corp (omsc).The malfunction of the subject device concerning this case has not been reported.The exact cause could not be determined.If additional information becomes available, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) received a literature titled "small intestine research group of the korean association for the study of intestinal disease (kasid), clinical outcome after enteroscopy for small bowel angioectasia bleeding: a korean association for the study of intestinal disease (kasid) multicenter study".The literature reported the result of 66 patients of the balloon-assisted endoscopy (bae) procedure using olympus small intestinal videoscope or fujinon enteroscope en-450p5/20 or en-450t5/20 from january 2003 to july 2014.In the subject cases, perforation occurred in one patient.Based on the available information, a direct relationship between the olympus product and the observed adverse events could not be determined.Therefore, omsc will submit a medical device reports (mdr) depending on the event.

• Brand Name: EVIS LUCERA SMALL INTESTINAL VIDEOSCOPE
• 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: 10352831
• MDR Text Key: 203305192
• Report Number: 8010047-2020-05100
• Device Sequence Number: 1
• Product Code: FDA
• Combination Product (y/n): N
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature,user facil
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/06/2020
• 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