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 Bacterial Infection (1735); Fever (1858); Pain (1994); Perforation (2001); Shock (2072); Peritonitis (2252)

Event Type  Injury  

Event Description

It is reported in the literature titled ¿outcomes of eus guided transluminal gallbladder drainage in patients without cholecystitis¿, patients in both study groups experienced adverse effects during or after procedures using an evis exera ii ultrasound gastrovideoscope.Study aim: cholecystectomy is the gold standard for most gallbladder related disease.However, many patients with gallbladder disease are poor surgical candidates.Current nonsurgical gallbladder drainage (gbd) methods include percutaneous cholecystostomy and endoscopic ultrasound guided transluminal gbd (eus gbd).Outcomes for eus gbd for the treatment of non-cholecystitis (nc) gallbladder disease have not been defined.Study method: cases were identified using procedural data from a quaternary academic hospital for endoscopic procedures from 2015 to 2020.Patients who underwent eus gbd for acute cholecystitis, biliary colic, gallstone pancreatitis, and secondary prevention of gallstone disease were included.Results: fifty five cases of eus gbd were identified over the 5 year study period.Forty one cases were performed for acute cholecystitis, and 15 were performed for other nc indications.Indications for nc drainage included primary treatment of symptomatic biliary colic and secondary prevention of gallstone pancreatitis and choledocholithiasis.There was no statistically significant difference in complications, mortality, or reintervention requirements.There was a 13.3% rate of immediate complications in the nc group, which were all medically managed.Conclusions: eus gbd appears to be a safe and effective way to manage gallstone disease in nonsurgical candidates with nc gallbladder related disease.Overall complications and readmissions were infrequent.Complication rates were similar to those published in patients who underwent eus gbd for acute cholecystitis.Case with patient identifier (b)(6) reports the eus-gbd-nc group.Case with patient identifier (b)(6) reports the eus-gbd-c group.(this report) in the eus-gbd-c group, there was a 14.6% rate of immediate complications among c patients (p = 0.90), including fevers (n = 1), undifferentiated shock (n = 1), persistent ruq pain (n = 1), bacteremia (n = 1), microperforation of the stomach antrum (n = 1, managed endoscopically during the initial procedure), and bile peritonitis (n = 1).All complications were managed medically or endoscopically as above and did not require surgical intervention.There was no report of olympus device malfunction in any procedure described in this literature.

Manufacturer Narrative

Concomitant medical products: concomitant devices: boston scientific lumen-apposing metal stents (lams), guidewire, double pigtail plastic stent, insufflator.The device referenced in this report has not been returned to olympus for evaluation.The investigation is ongoing.The definitive cause of the user¿s experience cannot be determined at this time.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.This event has been reported by the importer on mdr# 2951238 ¿ 2022- 00356.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device history record was unable to be reviewed for this device since the serial 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: 13756304
• MDR Text Key: 292349992
• Report Number: 8010047-2022-04360
• Device Sequence Number: 1
• Product Code: ODG
• UDI-Device Identifier: 04953170356339
• UDI-Public: 04953170356339
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093395
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Literature,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2022
• 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: 04/07/2022
• 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): Required Intervention; Other