MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS LUCERA DUODENOVIDEOSCOPE

Model Number JF-260V

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

Patient Problem Pancreatitis (4481)

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

The literature titled "a case of a 5-year-old boy who underwent ercp under general anesthesia for choledocholithiasis", reports a case study of a child who underwent and endoscopic retrograde cholangiopancreatography (ercp) under general anesthesia.A five year old child presented to the emergency room with a chief complaint of upper abdominal pain.On abdominal palpation, tenderness was observed in the right upper abdomen, and blood tests revealed elevated hepatobiliary enzymes: ast 218 u/l, alt 98 u/l, and ggtp 265 u/l.Suspecting biliary disease, a contrast-enhanced ct scan of the abdomen revealed an enlarged gallbladder, dilated common bile duct, and a 5-mm hyper absorbable area near the papillary vater's area, suggesting a stone.Based on the findings, a diagnosis of common bile duct stone disease was made.The patient was hospitalized and treated conservatively with fasting, but a blood test the next day showed elevated hepatobiliary enzymes: ast 461 u/l, alt 473 u/l, and ggtp 363 u/l.A second ct scan of the abdomen showed residual hyper absorptive areas in the papillary region, so the patient underwent endoscopic retrograde cholangiopancreatography (ercp).Because the patient was a child, the procedure was performed under general anesthesia, with the patient positioned in the left lateral recumbent position, and jf-260v (olympus) endoscope was used.The pharynx was passed without mucosal damage, the papilla was reached, and the bile duct was intubated, and cholangiography was performed without pancreatic duct misintubation.Contrast did not reveal any biliary malformation and no clear translucent image suggestive of stones was noted, but intraductal ultrasonography (idus) revealed sludge echoes, so the patient underwent endoscopic sphincterotomy (est) followed by removal of stones with a balloon catheter.The procedure was completed in 23 minutes with no bleeding, perforation, or other intraoperative complications.However, blood tests 2 hours after the examination revealed elevated pancreatic enzymes, including amylase 1868 u/l and lipase 5930 u/l.The patient was judged to have post-ercp pancreatitis and conservative treatment was started.Abdominal ct showed an elevated peripancreatic lipid concentration exceeding the sub renal pole, while the hyper absorptive area in the papillary region disappeared and the bile duct dilation improved.The patient's pancreatitis gradually improved with conservative treatment, and he was discharged from the hospital 10 days after ercp.Since then, the patient has had no symptom flare-ups and no post-pancreatitis complications for approximately 3 months to date.There is no report of device malfunction reported 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: 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 LUCERA DUODENOVIDEOSCOPE
• Type of Device: DUODENOVIDEOSCOPE
• 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: 14163651
• MDR Text Key: 294639139
• Report Number: 8010047-2022-06723
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 08/02/2022

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: JF-260V
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/23/2022
• Initial Date FDA Received: 04/20/2022
• Supplement Dates Manufacturer Received: 07/11/2022
• Supplement Dates FDA Received: 08/02/2022
• 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
• Patient Age: 5 YR
• Patient Sex: Male
• Patient Weight: 28 KG