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

Model Number SIF-H290S

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Not Applicable (3189)

Event Type  Injury  

Manufacturer Narrative

The subject device was 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.The malfunction of the subject device concerning this case has not been reported.The exact cause could not be determined.

Event Description

On may 11, 2018, olympus medical systems corp.(omsc) received a literature titled ¿study on ercp(endoscopic retrograde cholangiography) using short- type single balloon endoscope(sbe) for patients who experienced rouen-y intestinal reconstructive surgery¿.The literature reported the result of the 19 procedures of the ercp which were conducted between july 2016 and september 2017 at the user facility.In the 19 procedures, an olympus small intestinal videoscope sif-h290s was used.(however, in two of 19 procedure, olympus sif-q260 was used following the sif-h290s since the sif-h290s could not reach the target sites) the literature reported 3 case of mild pancreatitis as accidental symptoms related to the ercp procedures.In one of the 3 case of perforation, sif-h290s was apparently used.In the other two cases of perforation, sif-h290s and sif-q260 were possibly used.However, it was uncertain of whether the two scope were actually used in the two cases, and which scope attributed to the two perforations.According to the three accidental symptoms cases, omsc is submitting one medical device report (mdr) associated with sif-h290s and two mdrs associated with unspecified small intestine videoscope.This is two of three reports.

• Brand Name: EVIS LUCERA ELITE SMALL INTESTINALVIDEOSCOPE
• 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: 7580996
• MDR Text Key: 110451130
• Report Number: 8010047-2018-01093
• 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: 06/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 05/11/2018
• 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
• Patient Outcome(s): Other