MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS LUCERA DUODENOVIDEOSCOPE

Model Number UNKNOWN

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

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

There was no malfunction report of the subject device.Since the serial number of this device is unknown and olympus medical systems corp.(omsc) could not confirm the manufacturing history.The exact cause of the reported event could not be conclusively determined.

Event Description

On (b)(6) 2018, olympus medical systems corp.(omsc) received a literature titled ¿use of the conventional side-viewing duodenoscope for successful endoscopic retrograde cholangiopancreatography in post-gastrectomy patients¿.The literature reported that 220 procedures of endoscopic retrograde cholangiopancreatography were conducted using olympus duodenoscope (jf-260v or tjf-260v) between january 2009 and september 2014.In the subject procedures, 12 cases of complications reportedly occurred as follows; immediate bleeding : 2 cases.Pancreatitis : 9 cases.Perforation : 1 case.The literature concluded that the side-viewing duodenoscope is a useful instrument for performing successful endoscopic retrograde cholangiopancreatography in patients post-gasrectomy.Omsc is submitting medical device reports according to the number of complications.This is 5 of 12 reports.

• Brand Name: EVIS LUCERA DUODENOVIDEOSCOPE
• Type of Device: DUODENOVIDEOSCOPE
• 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: 7701917
• MDR Text Key: 114406048
• Report Number: 8010047-2018-01376
• Device Sequence Number: 1
• Product Code: FEB
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 07/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/20/2018
• Initial Date FDA Received: 07/19/2018
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other