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

Model Number GIF-2TQ260M

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Inflammation (1932)

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 from the facility.There was no malfunction report of the subject device concerning the events.The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) received a literature titled ¿can trainees safely perform endoscopic treatments for common bile duct stones? a single-center retrospective study¿.The literature reported the result of ercp (endoscopic retrograde cholangiopancreatography) procedures for 325 patients at the user facility between january 2009 and december 2014.In the subject procedures, pancreatitis occurred in 39 patients, cholangitis occurred in 7 patients and bleeding occurred in 5 patients.The literature reported that olympus duodenovideoscope (tjf-240 and jf-260v), colonovideoscope (cf-q240ai) and gastrointestinalvideoscope (gif-2t260m) were used in the procedures.There was no information on which model of the endoscope was used in each procedure.Further detailed information could not been obtained at present.According to the number of the type of complication (pancreatitis, cholangitis and bleeding), omsc is submitting 3 medical device reports for each endoscope model (total 12 of mdrs).This is a report on cholangitis in gif-2t260m and 11 of 12 reports.

• Brand Name: EVIS LUCERA GASTROINTESTINAL VIDEOSCOPE
• Type of Device: GASTROINTESTINAL 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: 7913629
• MDR Text Key: 121857005
• Report Number: 8010047-2018-01868
• Device Sequence Number: 1
• Product Code: FDS
• 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: 09/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: GIF-2TQ260M
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/29/2018
• 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