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

Model Number TJF-Q180V

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

Patient Problems Inflammation (1932); Perforation (2001); Obstruction/Occlusion (2422)

Event Type  Injury  

Manufacturer Narrative

The subject device was not returned to olympus medical systems corp.(omsc) for evaluation.Therefore, the exact cause of the reported event could not be conclusively determined.Since the serial number is unknown, the device history record could not be reviewed.However, omsc has only shipped devices that passed the inspection.In the literature, there is no description of the device's malfunction.

Event Description

On november 24, 2020, olympus medical systems corp.(omsc) received literature titled "laparoscopy-assisted versus balloon enteroscopy-assisted ercp after roux-en-y gastric bypass".This study was conducted the endoscopic retrograde cholangiopancreatography (ercp) for 68 patients post-roux-en-y gastric bypass surgery between may 2013 and december 2017.The procedure of ercp was used by the subject device.In the literature, it was reported that as minor event pancreatitis, perforation, bleeding, cholangitis, intra-abdominal, kidney failure, and pain occurred.And, it was reported 4 serious injuries.These serious injuries were perforation of balloon enteroscopy-assisted ercp (bea-ercp), cholangitis, small-bowel obstruction, and small-bowel perforation and hernia of laparoscopy-assisted (lap-ercp).The procedure of bea-ercp was used by the subject device (sif-q180), and lap-ercp was used by tjf-q180v.Based on the available information, detailed information of the subject device was not provided, and there is no description of the relationship between the events and the subject device.However, omsc assumes that the 4 cases of serious injury might be related to the subject device since the subject device was used for the ercp procedure.There is no description of the device's malfunction.Omsc will submit 2 medical device report (mdr) for the event the medical device.This is a report regarding lap-ercp with tjf-q180v.

• Brand Name: EVIS EXERA II 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: 10957044
• MDR Text Key: 219881129
• Report Number: 8010047-2020-09918
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: K143153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/07/2020

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: No Information
• Device Model Number: TJF-Q180V
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/24/2020
• Initial Date FDA Received: 12/07/2020
• 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