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 Fever (1858); Pain (1994)

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.(this report) case with patient identifier (b)(6) reports the eus-gbd-c group.In the eus-gbd-nc group, there was a 13.3% rate of immediate complications among nc patients, which were due to postprocedural fever (n = 1) and persistent ruq pain (n = 1); the patient with fever was medically managed, though the patient with persistent ruq pain underwent ercp with sphincterotomy on postprocedure day 3.There was no report of olympus device malfunction in any procedure described in this literature.

• 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: 13756183
• MDR Text Key: 287103866
• Report Number: 2951238-2022-00355
• 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: 02/14/2022,03/14/2022

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: 02/14/2022
• Event Location: Hospital
• Date Report to Manufacturer: 02/14/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/14/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention