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 Hemorrhage/Bleeding (1888); Perforation (2001); Pancreatitis (4481); Unspecified Hepatic or Biliary Problem (4493)

Event Date 12/02/2021

Event Type  Injury  

Manufacturer Narrative

The suspect device has not been returned to olympus for evaluation.The investigation is in process.Tjf-260v may have been used but the authors did not specify.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 a literature titled "endoscopic retrograde cholangiopancreatography-related complications for bile duct stones in asymptomatic and symptomatic patients".This retrospective multicenter study was aimed to compare the risks of endoscopic retrograde cholangiopancreatography (ercp) for the removal of common bile duct (cbd) stones, between asymptomatic and symptomatic patients.The study included 1491 patients with choledocholithiasis at three institutions in (b)(6) and was evaluated for the incidence rates of overall ercp-related complications and the severity as the primary outcome.The secondary outcomes were the incidence rates and severities of each ercp-related complication such as; post-ercp pancreatitis (pep), perforation.Cholangitis, and bleeding.The reported rates for complications were 7.5% in the asymptomatic group vs 6.1% in the symptomatic group (p < 0.001).The study concluded that, however, both the groups were at equal risks of post-ercp cholangitis, bleeding, and perforation; but, ercp for asymptomatic patients with cbd stones had a higher risk of overall complications than that for symptomatic patients.The authors reported using two different olympus evis lucera duodenoscopes, jf-260 or tjf-260v and did not specify which scope was used on the patients with adverse events.Jf-260v was selected as a representative product.[asymptomatic group; n = 172]: overall ercp-related complications - (31).Mild post-ercp pancreatitis (pep) - (10).Moderate pep - (8).Severe pep - (3).Mild-cholangitis - (2).Moderate-cholangitis - (2).Mild-bleeding - (1).Moderate-bleeding - (1).Severe-bleeding - (1).Mild -perforation - (1).Moderate -perforation - (1).Severe -perforation - (1).[symptomatic group; n = 1319]: overall ercp-related complications - (81).Mild pep - (27).Moderate pep - (7).Severe pep - (1).Mild-cholangitis - (13).Moderate-cholangitis - (6).Mild-bleeding - (15).Moderate-bleeding - (4).Severe-bleeding - (2).Mild -perforation - (2).Moderate -perforation - (4).

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 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: 13733872
• MDR Text Key: 291597298
• Report Number: 8010047-2022-04285
• 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: 07/01/2022

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: 02/13/2022
• Initial Date FDA Received: 03/11/2022
• Supplement Dates Manufacturer Received: 06/03/2022
• Supplement Dates FDA Received: 07/01/2022
• 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