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

Model Number GF-UCT180

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

Patient Problems Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Pancreatitis (4481)

Event Date 06/16/2020

Event Type  Injury  

Event Description

In the literature titled ¿eus-directed transgastric endoscopic retrograde cholangiopancreatography versus laparoscopic-assisted ercp versus deep enteroscopy-assisted ercp for patients with rygb,¿ patients experienced adverse events during and after procedures using olympus scopes.Case with patient identifier (b)(6) reports the gf-uct180 used in procedures.Case with patient identifier (b)(6) reports the tjf-q180v used in procedures.Study background/aim: endoscopic ultrasound-directed transgastric endoscopic retrograde cholangiopancreatography (ercp) (edge) is a novel technique for managing pancreaticobiliary diseases in patients with a history of roux-en-y gastric bypass (rygb).It has shown to have high technical success rates and fewer adverse events as compared to laparoscopic-assisted ercp (la-ercp).We compared the technical success and clinical outcomes of edge vs.La-ercp vs.E-ercp.Methods: a retrospective chart review was performed for 56 patients, of whom 18 underwent la-ercp, 12 underwent e-ercp, and 26 had edge, and a comparison of technical success and complication rates was done.Results: baseline demographic characteristics of patients undergoing these procedures, including age and gender, were comparable.The technical success rate for patients in the edge group were 100 % (n = 26), compared with 94 % (n = 17) and 75 % (n = 9) in the la-ercp and e-ercp groups (p = 0.02).In the edge group, 8 % of patients (n = 2) had bleeding, and 4 % of patients (n = 1) had lumen-apposing metal stent migration occur during the procedure.In the la-ercp group 6 % (n = 1) of patient had bleeding, 6 % (n=1) post-ercp pancreatitis and 6 % (n = 1) were diagnosed with an intra-abdominal infection post-procedure.Time to complete the edge procedure was significantly shorter at 79 ± 31 mins, compared with 158 ± 50 mins for la-ercp and 102 ± 43 mins for e-ercp (p < 0.001).Conclusion: edge is a novel procedure with short procedure times and an effective alternative to la-ercp and e-ercp in management of pancreaticobiliary diseases in patients with a history of rygb.In the edge group, 92 % (n = 24) had a 15-mm lams placed and 8 % (n = 2) had a 20-mm lams placed.This was at the discretion of the performing endoscopist.Eight percent of patients (n = 2) had sphincterotomy-related bleeding, and 4 % of patient (n = 1) had lams migration occur during the procedure.In the la-ercp group 6 % of patients (n = 1) had sphincterotomy-related bleeding, 6 % (n = 1) post-ercp pancreatitis and 6 % (n = 1) were diagnosed with an intra-abdominal infection post-procedure.In the e-ercp group 25 % of patients (n = 3) had sphincterotomy-related bleeding, 8 % (n = 1) had infection and 8 % (n = 1) were diagnosed with post-ercp pancreatitis.There is no report of olympus device malfunction described in this study.

• Brand Name: EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE
• Type of Device: ULTRASOUND GASTROVIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 14277862
• MDR Text Key: 290782888
• Report Number: 2951238-2022-00391
• Device Sequence Number: 1
• Product Code: ODG
• UDI-Device Identifier: 04953170356339
• UDI-Public: 04953170356339
• 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: 04/04/2022,05/03/2022

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: GF-UCT180
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/04/2022
• Event Location: Hospital
• Date Report to Manufacturer: 04/04/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/04/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other