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

Model Number TGF-UC180J

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

Patient Problems Hemorrhage/Bleeding (1888); Septic Shock (2068)

Event Date 07/18/2021

Event Type  Death  

Manufacturer Narrative

The device referenced in this report has not been returned to olympus for evaluation.The investigation is ongoing.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.

Event Description

It is reported in the literature article titled:¿ endoscopic internal drainage of complex bilomas and biliary leaks by transmural or transpapillary/transfistulary access,¿ patient experienced adverse events during and after procedures using olympus devices.Case with patient identifier (b)(6) reports gf-uct140-al5 (for death of patients).Case with patient identifier (b)(6) reports gf-uct140-al5(for adverse events other than death).Case with patient identifier (b)(6) reports tgf-uc180j (for death of patients).Case with patient identifier (b)(6) reports tgf-uc180j (for adverse events other than death).Case with patient identifier (b)(6) reports tjf-160vr (for death of patients).Case with patient identifier (b)(6) reports tjf-160vr (for adverse events other than death).Case with patient identifier (b)(6) reports tjf-q180v (for death of patients).Case with patient identifier (b)(6) reports tjf-q180v (for adverse events other than death).Study background and aim: bilomas most frequently result from postoperative bile leaks.The endoscopic conventional treatment is sphincterotomy stent placement.In complex cases, such as altered anatomy or failure of conventional treatment, transpapillary/transfistulary (tp/tf) drainage or eus-guided transmural drainage (eus-td) may obviate additional biliary surgery.This study reports our experience with treating biloma secondary to refractory biliary leak with tp/tf drainage or eus-td and evaluates the safety and outcomes associated with this approach.Methods: this observational study focused on consecutive patients managed for biliary leakage (diagnosis based on imaging and/or bile outflow from a surgical drain) at a tertiary care hospital (2007-2017).Tp/tf drainage was performed by double-pigtail stent(s) placement to drain the biloma through the leak during ercp.For eus-td, plastic stent(s) were placed under eus control.Primary outcomes were a composite of clinical success (patient free of sepsis after percutaneous drain removal and, in patients with benign disease, removal of all endoscopically placed stents, without need for reintervention) and biloma regression (<3cm) at last follow-up.Results: thirty patients (men, 57%; median age, 55 years) were included.Most biliary leaks resulted from chole cystectomy (27%) and hepatectomy (50%).Initial eus-td and tp/tf drainage were performed in 14 (47%) and 16 (53%) patients, respectively.At last follow-up (median, 33.2 months), clinical success and primary outcome were achieved in 70.4% of patients (eus-td, 75%; tp/tf, 67%).Additional surgery was necessary in 1 patient.Rate of serious adverse events was 23% (7/30), of which 13% (4/30) were procedure related.There were 4 deaths during the course of treatment, 2 of which were related to endoscopic interventions (hemorrhage and fibrillation).Conclusions: tp/tf drainage or eus-td is technically feasible with high clinical success and may avoid the need for additional surgery in complex cases or in patients with altered anatomy.Efficacy monitoring was available for 27 patients and un available because of death during endoscopic treatment period in 3 patients (2 because of endoscopic treatment¿s adverse event and 1 because of leakage and septic shock).The median length of follow-up was 33.2 months.Among these 27 patients, 2 had a redo percutaneous drainage and 1 had a redo surgery.After treatment of complex biliary leak, 6 patients (25%) developed secondary biliary strictures that resolved after endoscopic multiple plastic stent placement treatment in the following months.Ten of 30 patients (33%): 2 after the underlying endoscopic treatment from septic shock associated with the biliary leak (including 1 patient who died 6 years after the removal of the pigtail stents 6 months after their placement, which had allowed the closure of the biliary leak), 1 from septic shock during a further biliary stricture stent placement procedure, and 5 from cancer progression.There is no report of any olympus device malfunction reported in any procedure described in this literature.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.New information was added to the following fields: d4, d8, h6, h10.The device history record was unable to be reviewed for this device since the lot number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, the relationship between the device and the adverse event cannot be confirmed.There was no complaint reported on the subject device.There is no evidence of an olympus device malfunction.Olympus will continue to monitor field performance for this device.

• 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 14578194
• MDR Text Key: 293246316
• Report Number: 8010047-2022-09295
• Device Sequence Number: 1
• Product Code: ODG
• UDI-Device Identifier: 04953170355493
• UDI-Public: 04953170355493
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K093507
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TGF-UC180J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/16/2022
• 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): Death