MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SIF-Y0004; SMALL INTESTINAL VIDEOSCOPE

Model Number UNKNOWN

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Inflammation (1932); Perforation (2001); Pneumonia (2011)

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 by 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 received literature titled ¿a study of single-balloon endoscopic treatment for pancreatic biliary tract disease associated with patients having reconstructed gastrointestinal anatomy in our hospital.¿ that was made in public in japan digestive disease week (jddw).The literature reported the result of 27 cases of the endoscopic treatment using olympus single balloon enteroscope between april 2008 to october 2017.In the procedures, following accidental symptoms reportedly occurred.Pancreatitis: 4 cases; bile duct inflammation: 1 case; micro perforation: 3 cases; aspiration pneumonia: 1 case.Three cases of perforation improved by conservative medical treatment.Olympus reviewed the delivery history of endoscopes for the facility and confirmed olympus sif-h290s, sif-y0004-v01, sif-y0015, and sif-q260 were delivered.Olympus is submitting mdr according to the number of accidental symptoms case because it was not informed that which endoscope model was used in the procedures.This report is 1 of 9 reports.

• Brand Name: SIF-Y0004
• 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: 7572270
• MDR Text Key: 110173944
• Report Number: 8010047-2018-00994
• 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: 06/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: UNKNOWN
• Device Lot Number: UNKNOWN
• 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