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

Model Number SIF-Q260

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Laceration(s) (1946)

Event Type  Injury  

Manufacturer Narrative

The subject device was not been returned to omsc.Omsc could not review the service and manufacturing record because the serial number was not provided from the facility.The malfunction of the subject device concerning this case has not been reported.The exact cause could not be determined.

Event Description

Olympus medical systems corp.(omsc) received a literature titled ¿usefulness of biliary and pancreatic treatment endoscopy in cases after gastrointestinal tract surgery¿.The literature reported the result of 72 patients who underwent endoscopic retrograde cholangiopancreatography (ercp) for after gastrointestinal tract surgery between january 2008 and december 2018.There was no detailed information on which model of the endoscope was used in each procedure.The literature only provided a part of model names, ¿q260j¿, ¿jf¿, ¿pcf¿, ¿sif¿ and ¿h290¿.However, omsc presumed based on a delivery record that these models were gif-q260j, jf-260v, pcf-q260ji, sif-q260 and gif-h290.In the subject procedures, 1 case of small intestinal mucosal tear, 1 case of small intestinal perforation requiring emergency surgery, and 1 case of duodenal perforation reportedly occurred.Based on the available information, the small intestinal mucosal tear and the small intestinal perforation requiring emergency surgery were associated with endoscopic insertion.However, a direct relationship between the endoscopes and the duodenal perforation could not be determined.This is 1 of 3 reports for the sif-q260 which may involved in the small intestinal mucosal tear.

• 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: 8779524
• MDR Text Key: 150717733
• Report Number: 8010047-2019-02510
• 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,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SIF-Q260
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/13/2019
• 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