MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE

Model Number GF-UCT180

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

Patient Problem Insufficient Information (4580)

Event Date 08/08/2022

Event Type  Death  

Manufacturer Narrative

Since the literature described "gif uct180", olympus selected "gf-uct180" as a representative product.The suspect device has not been returned to olympus for evaluation.The investigation is in process.The literature article is attached for additional information.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.

Event Description

Olympus reviewed the following literature titled "eus-guided biliary drainage in patients with moderate¿severe cholangitis is safe and effective: a multi-center experience." this is a retrospective review of a prospectively maintained endoscopy database to assess outcomes of endoscopic ultrasound-guided biliary drainage (eus-bd) in patients with moderate¿severe cholangitis.A total of 263 cases of eus-bd were reviewed.Of the 49 patients (23 male; 46.9%) presenting with moderate/severe cholangitis, 23 (46.9%) had severe cholangitis.Clinical success with improvement of cholangitis, on the overall cohort, was 91.7% (44/48).Effective biliary drainage (ebd) defined as reduction in bilirubin by more than 50% of baseline at 2 weeks, and/or bilirubin<3.0 mg/dl at 4 weeks.Ebd, on the overall cohort, was noted in 85.4% (41/48) cases.Adverse events in the form of mostly bleeding and bile leak were noted in 5 cases (10.2%) but managed conservatively.Distal obstruction exhibited significantly better clinical success (100% vs.78.9%; p=0.02) than hilar obstruction.In conclusion, in case of failed/non-feasible ercp, eus-bd can be a safe and an effective alternative option for patients with moderate to severe cholangitis, even with significant pre-morbid conditions, with acceptable adverse events rate.Type of adverse events/number of patients: bleeding : 1 patient.Intrahepatic cholestasis : 1 patient.Hemobilia : 2 patients.Bile leak :1 patient.Death 2 days after procedure due to massive pulmonary embolism : 1 patient.Death 3 months after procedure : 10 patient.This literature article requires 2 reports.The related patient identifiers are as follows: (b)(6): for adverse events.(b)(6): for patient death.This medwatch report is for patient identifier (b)(6).There is no report of any olympus device malfunction in any procedure described in this study.

• Brand Name: EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE
• Type of Device: ULTRASOUND GASTROVIDEOSCOPE
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer (Section G): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16659067
• MDR Text Key: 312489156
• Report Number: 3002808148-2023-03212
• Device Sequence Number: 1
• Product Code: ODG
• UDI-Device Identifier: 04953170356339
• UDI-Public: 04953170356339
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K093395
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2023
• 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?: No
• Date Manufacturer Received: 03/06/2023
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Death