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

Model Number UNKNOWN

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

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

Event Description

On (b)(6) 2017, olympus medical systems corp (omsc) received a literature titled ¿treatment efficacy of short-type single-balloon endoscopy (s-sbe) using for patients who experienced intestinal reconstructive surgery in endoscopic retrograde cholangiography (ercp)¿ that was made in public in japan digestive disease week (jddw) on october 2017.The literature reported the result of 74 cases; 144 procedures (before s-sbe introduction: 119 procedures, after s-sbe introduction: 25 procedures) between january 2013 and february 2017.In the subject procedures, following complications reportedly occurred.- before s-sbe introduction: perforation occurred in 2 procedures, and pancreatitis occurred in 6 procedures.- after s-sbe introduction: perforation occurred in 0 procedure, pancreatitis occurred in 3 procedures.The literature concluded that, s-sbe was considered to be useful because it enables to perform a safe and wide-ranging treatment in ercp for patients who experienced intestinal reconstructive surgery.The presenter of the literature stated that olympus endoscope model sif-h290s, sif-q260, gif-xq260, gif-2t240 and gif-xq260j were used for the procedures (omsc reviewed the sales history record and confirmed that the facility did not purchased the gif-xq260j but gif-q260j).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 is 5 of 11 reports.

Manufacturer Narrative

This supplemental report is submitted to correct "device product code.".

• Brand Name: EVIS GASTROINTESTINAL VIDEOSCOPE
• Type of Device: GASTROINTESTINAL VIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to
• Manufacturer Contact: katsuaki morita ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 7012516
• MDR Text Key: 91443224
• Report Number: 8010047-2017-01696
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup
• Report Date: 03/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/13/2019
• 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