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 Problems Pancreatitis (4481); Unspecified Hepatic or Biliary Problem (4493)

Event Type  Injury  

Manufacturer Narrative

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 article: "risk factors for cholecystitis after metal stent placement for distal malignant biliary obstruction." abstract: to identify the risk factors and clinical results for acute cholecystitis after covered self-expandable metal stent (sems) placement for distal malignant biliary obstruction (mbo), we have retrospectively examined the clinical outcomes in patients with acute cholecystitis after endoscopic biliary sems placement for distal mbo.This was a retrospective study.Between january 2014 and june 2017, 90 patients who were identified to have underwent endoscopic covered sems placement for distal mbo at our institution were included in this analysis.Patients with benign biliary strictures after cholecystectomy were excluded.After covered sems placement, we followed up with physical examination and laboratory data and continued with the follow-up for as long as possible.The risk factors for acute cholecystitis after covered sems placement were then evaluated.Acute cholecystitis was observed in 15 patients (17%) after covered sems placement.The median time to the onset of acute cholecystitis after covered sems placement was 19 days (interquartile range, 5-127 days).Cholecystitis was initially treated with percutaneous gallbladder aspiration (ptgba) in 11 patients, percutaneous gallbladder drainage (ptgbd) in 2 patients, and antimicrobial therapy alone in 2 patients.Five patients (including four patients treated with ptgba and one patient treated with antimicrobial therapy alone) had cholecystitis recurrence.In a multivariate analysis of the risk factors for cholecystitis after covered sems placement, bile duct cancer (odds ratio (or), 12 ; p=0.028), thin bile duct diameter ( = 8 mm) (or, 5.2 ; p=0.048), and chemotherapy (or, 12.6 ; p=0.008) were identified as the significant risk factors.Bile duct cancer, thin bile duct diameter, and chemotherapy were identified as risk factors for acute cholecystitis after endoscopic covered sems placement for distal mbo.Ptgba is useful as the initial treatment for acute cholecystitis after covered sems placement for distal mbo ; however, cholecystitis recurrence should be taken into consideration.The authors reported the following adverse events: acute pancreatitis after sems placement (9).Acute cholecystitis (n=15): early cholecystitis occurred in 9 patients, late cholecystitis occurred in 6.The severity of cholecystitis was mild in 13 patients, moderate in 1 patient, and severe in 1 patient.One patient with mild cholecystitis had liver abscess.Percutaneous gallbladder aspiration (ptgba) in 11 patients, percutaneous gallbladder drainage (ptgbd) in 2 patients, and antimicrobial therapy alone in 2 patients.Five patients (including four patients who had ptgba and one patient who received antimicrobial therapy alone) had cholecystitis recurrence.In two patients whose cholecystitis was not relieved with ptgba, eusgbd was performed.   .

Event Description

Additional information received from the author: the medical opinion of the author states the olympus device did not cause or contribute to the adverse events reported in the study.

Manufacturer Narrative

This supplemental report is being submitted to provide the additional information from the author and legal manufacturer's investigation.New information added to the following fields: b5, h3, h6, h10.The device history records (dhr) for this device could not be reviewed since the serial number was not provided.Olympus ships devices manufactured according to all applicable procedures and meet final product release criteria.A definitive root cause was not identified.Based on the available information, the legal manufacturer was unable to determine the probable cause of the adverse events since the device was not returned for evaluation.

• 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: 14400048
• MDR Text Key: 294760710
• Report Number: 8010047-2022-08234
• 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,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/20/2022

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: 04/13/2022
• Initial Date FDA Received: 05/13/2022
• Supplement Dates Manufacturer Received: 05/23/2022
• Supplement Dates FDA Received: 06/20/2022
• 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
• Treatment: VISIGLIDE.
• Patient Outcome(s): Other; Required Intervention