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 Fistula (1862); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Unspecified Hepatic or Biliary Problem (4493)

Event Date 05/16/2021

Event Type  Injury  

Manufacturer Narrative

The literature reports jf-260v or tjf-260v, jf-260v chosen as a representative device.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.

Event Description

It is reported in the literature titled¿ utility of the inside stent as a preoperative biliary drainage (pbd) method for patients with malignant perihilar biliary stricture,¿ patients experienced adverse events after endoscopic nasobiliary drainage (enbd) procedures using olympus devices.Case with patient identifier (b)(6) reports jf-240.Case with patient identifier (b)(6) reports jf-260v.Study aim: the aim of this study was to clarify the utility of inside stents in pbd.Method: eighty-one patients with malignant perihilar biliary stricture who underwent endoscopic nasobiliary drainage (enbd) as the first pbd method were en rolled.Biliary stenting was performed in 61 patients during the study course (41 patients¿inside stent implanted in the bile duct; 20 patients¿conventional stent placed across the papilla of vader).Twenty patients continued enbd until surgery.Treatment outcomes were compared among the three groups.Results the re-intervention rate was significantly lower in the inside stent group than in the conventional stent group and enbd group (9.8% vs 40% and 35%, p =.013 and.030, respectively), and the time to re-intervention was also significantly longer (log-rank: p =.004 and.041, respectively).Of the five patients in the inside stent group who underwent neoadjuvant chemotherapy, only one required re-intervention.There was no significant difference in the incidence of postoperative complications among the three groups.Conclusion: the inside stent may be a useful pbd method for patients with malignant perihilar biliary stricture.Across all study groups patients experienced severe post-operative complications including biliary fistula, infection, bleeding, liver failure, and in-hospital mortality.In this study, in-hospital deaths were observed in six patients (7.4%).All six patients who died in the hospital were classified as bismuth iii and iv, and five died of liver failure.Only one patient who died in the hospital underwent re-intervention for cholangitis during pbd.However, when the preoperative indocyanine green retention rate of the in-hospital dead and surviving patients was compared, it was significantly higher in the in-hospital dead patients (data not shown).Therefore, preoperative liver dysfunction may have had a greater effect on in-hospital mortality than preoperative cholangitis.(both liver dysfunction and pre-operative cholangitis were pre-existing conditions in these patients).There is no report of olympus device malfunction described in this study.

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: b3, 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: 14102736
• MDR Text Key: 294526188
• Report Number: 8010047-2022-06199
• 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

• Date FDA Received: 04/13/2022
• 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
• Date Manufacturer Received: 07/11/2022
• 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; Required Intervention