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 Fistula (1862); Perforation (2001); Blood Loss (2597); No Code Available (3191); Pancreatitis (4481)

Event Type  Injury  

Event Description

Olympus received an article titled¿ an international, multicenter, comparative trial of eus-guided gastrogastrostomy-assisted ercp versus enteroscopy-assisted ercp in patients with roux-en-y gastric bypass anatomy.¿ the study aimed to compare the procedural outcomes and adverse events (aes) between eus-guided gg-assisted ercp (eus-gg-ercp) and enteroscopy-assisted ercp (e-ercp) in patients with roux-en-y gastric bypass (rygb).Patients with rygb anatomy who underwent eus-gg-ercp or e-ercp between 2014 and 2016 at 5 tertiary centers were included (4 american and 1 european).The primary outcome was technical success of ercp.Secondary outcomes included total procedural time, length of hospital stay, and rate/severity of aes.The technical success rate was significantly higher in the eus-gg-ercp versus the e-ercp group (100% vs 60.0%).Total procedure time was significantly shorter in patients who underwent eus-gg- ercp (49.8 min vs 90.7 min).The study concluded that eus-gg-ercp might be superior to e-ercp in patients with rygb anatomy in terms of a higher technical success and shorter procedural times and offered a similar safety profile.There were three reported adverse events associated with enteroscopy-assisted ercp (n=30):post-ercp pancreatitis (pep) - (1), post-ercp cholangitis - (1), small-bowel perforation - (1).The patients that experienced post-ercp cholangitis and small bowel perforation required operative intervention.One of these adverse events was deemed mild, one moderate and one severe.There were no fatal events reported.The e-ercp procedures were performed using either a single use enteroscope (olympus- model/serial# unknown) or a double balloon enteroscope (fujifilm).The following adverse events reported under eus-gg-ercp ( n=30): one patient had intraprocedural bleeding (1), which was managed conservatively with blood transfusion (1 unit) and the no endoscopic intervention.The other patient had persistent fistula (1) diagnosed on upper gi series 6 weeks after attempted closure with endoscopic suturing and subsequently underwent successful otsc closure.The eus gg ercp procedures used the following devices: gf-uct180 (olympus-serial# unknown), 19 gauge eus needle (boston scientific), or echotip needle (cook medical),.025 visiglide needle (olympus), 6mm balloon (boston scientific), therapeutic duodenoscope model tjf-q160v, and non-therapeutic duodenoscope jf-q180v.Since no specific information as to which of these devices were used on which patients, and procedures, olympus has decided to create one complaint against the tjf-q180v because olympus does not have a therapeutic duodenoscope model tjf-q160v.Cross-reference mfr.Report number: 8010047 - 2020 - 08090.

• 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
• MDR Report Key: 10731152
• MDR Text Key: 213148596
• Report Number: 2951238-2020-00509
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/24/2020,10/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TJF-Q180V
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/24/2020
• Event Location: Hospital
• Date Report to Manufacturer: 09/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention