MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. UNKNOWN; 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 ¿current status and problems of treatment with a short single-balloon endoscope for pancreatic, biliary tract disease in patients having reconstructed gastrointestinal anatomy¿ that was made in public in japan digestive disease week (jddw).The literature reported the result of 123 cases of the endoscopic retrograde cholangiopancreatography using olympus single balloon enteroscope between august 2011 to october 2017.In the procedures, following complications reportedly occurred.Mild pancreatitis: 3, bile duct inflammation: 4, perforation: 3, aspiration pneumonia: 1.Two cases of perforation required emergency surgery, but others improved by conservative treatment.Olympus reviewed the delivery history of endoscopes for the facility and confirmed sif-290s, sif-y0004, and sif-y0015 were delivered.Olympus is submitting mdr according to the number of complication case because it was not informed which endoscope model was used in the procedures.This report is 10 of 11 reports.

• Brand Name: UNKNOWN
• 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: 7576775
• MDR Text Key: 110334985
• Report Number: 8010047-2018-01032
• 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: 06/07/2018

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?: 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