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

Model Number TJF-260V

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

Patient Problem Pancreatitis (4481)

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 titled "critically ill patients with biliary obstruction and cholangitis: bedside fluoroscopic-free endoscopic drainage versus percutaneous drainage." abstract: severe acute cholangitis is a life-threatening medical emergency.Endoscopic biliary drainage (ebd) or percutaneous transhepatic biliary drainage (ptbd) is usually used for biliary decompression.However, it can be risky to transport a critical patient to the radiology unit.We aimed to compare clinical outcomes between bedside, radiation-free ebd and fluoroscopic-guided ptbd in patients under critical care.Methods: a retrospective study was conducted on critically ill patients admitted to the intensive care unit with biliary obstruction and cholangitis from (b)(6) 2011 to (b)(6) 2020.Results: a total of 16 patients receiving ebd and 31 patients receiving ptbd due to severe acute cholangitis were analyzed.In the ebd group, biliary drainage was successfully conducted in 15 (93.8%) patients.Only one patient (6.25%) encountered post-procedure pancreatitis.The 30-day mortality rate was no difference between the 2 groups (32.72% vs.31.25%, p 0.96).Based on multivariate analysis, independent prognostic factors for the 30-day mortality were a medical history of malignancy other than pancreatobiliary origin (hr: 5.27, 95% confidence interval ci: 1.01¿27.57) and emergent dialysis (hr: 7.30, 95% ci: 2.20¿24.24).Conclusions: bedside ebd is safe and as effective as percutaneous drainage in critically ill patients.It provides lower risks in patient transportation but does require experienced endoscopists to perform the procedure.In our hospital, the percutaneous trans-hepatic biliary drainage (ptbd) was typically used for biliary decompression.Some patients received bedside ebd in the icu without fluoroscopy due to various contraindications for ptbd insertion.Adverse events: n=1: mild pancreatitis.N=5: death after procedure with olympus device.Based on multivariate analysis, independent prognostic factors for the 30-day mortality were a medical history of malignancy other than pancreatobiliary origin (hr: 5.27, 95% confidence interval ci: 1.01¿27.57) and emergent dialysis (hr: 7.30, 95% ci: 2.20¿24.24).Conclusions: bedside ebd is safe and as effective as percutaneous drainage in critically ill patients.This article includes 2 reports as follows: (b)(6): since the literature described "tjf-260," we selected "tjf-260v" as a representative product; adverse event.(b)(6): since the literature described "tjf-260," we selected "tjf-260v" as a representative product; deaths.This is report 1 of 2 for (b)(6): since the literature described "tjf-260," we selected "tjf-260v" as a representative product; adverse event.

Event Description

The author provided additional information and reported there was no relationship between the olympus device and adverse event.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information from the author.New information added to b5.Correction to b1: based on the author's response, the event has been determined not reportable.

• 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: 14219220
• MDR Text Key: 290167246
• Report Number: 8010047-2022-07112
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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: 06/15/2022

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: TJF-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: 03/31/2022
• Initial Date FDA Received: 04/27/2022
• Supplement Dates Manufacturer Received: 05/17/2022
• Supplement Dates FDA Received: 06/15/2022
• 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): Other