MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE ASPIRATION NEEDLE NA-U200H

Model Number NA-U200H-8025

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

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 01/04/2021

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

It is reported in the literature titled ¿bile aspiration during eus guided hepaticogastrostomy is associated with lower risk of postprocedural adverse events: a retrospective single center study¿, patients experienced adverse events during or after procedures using olympus devices.Case with patient identifier (b)(6) reports gf-uct260 used in the procedures case with patient identifier (b)(6) reports na-u200h-8025 used in the procedures study background/aim: in endoscopic retrograde cholangiopancreatography (ercp), reduction of pressure inside of the bile duct by bile aspiration is a well-known method to lower the rate of adverse events (aes) including cholangitis.Endoscopic ultrasound guided hepaticogastrostomy (eus-hgs) has been introduced as an alternative to ercp.The use of self-expandable metallic stents is recommended in eus-hgs to reduce bile leak; however, other methods to reduce the rate of aes including bile leak, abdominal pain, fever, and sepsis, have not been elucidated yet.This study investigated whether bile aspiration during eus-hgs decreased the rate of postprocedural aes.Methods s decreased the rate of postprocedural aes.Methods consecutive patients who underwent eus-hgs between july 2016 and april 2020 were retrospectively evaluated in this study.Eus-hgs was performed at a tertiary cancer center.Patient characteristics, site of biliary obstruction, the quantity of bile aspirated during eus-hgs, type of stent, whether or not antegrade stenting (as) was performed, procedure time, and aes were assessed based on a prospectively recorded institutional endoscopy database.Logistic regression analysis was performed to identify factors affecting postprocedural aes.Results: ninety-six patients were included in the study.Eus-guided hgs with and without as was performed in 45 and 51 patients, respectively.Bile was aspirated in 71 patients (74%).The quantity of bile aspirated was 0¿10 ml and >10 ml in 40 and 56 patients, respectively.Aes including fever, abdominal pain, postprocedural cholangitis, sepsis, acute pancreatitis, and bleeding occurred in 45 patients (47%).The ae rates were 65% (26/40) and 34% (19/56), for 0¿10 ml and >10 ml bile, respectively (p=0.004).Using multivariate analysis, the only independent factor affecting he occurrence of aes was found to be an aspirated bile amount of 0¿10 ml (odds ratio: 4.16; 95% ci 1.6¿10.8).Conclusion: bile aspiration of more than 10 ml during eus-hgs contributes to reducing the rate of postprocedural aes.Two patients developed bleeding, the ct on the subsequent day revealed hematoma surrounding the hgs stent.Angiography did not show contrast media extravasation; however, transfusion was required.The severity grades of the remaining aes were mild.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.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: SINGLE USE ASPIRATION NEEDLE NA-U200H
• Type of Device: SINGLE USE ASPIRATION NEEDLE
• 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: 14400609
• MDR Text Key: 294761829
• Report Number: 8010047-2022-08237
• Device Sequence Number: 1
• Product Code: FCG
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K180449
• 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: 06/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: NA-U200H-8025
• Device Lot Number: UNKNOWN(LITERATURE)
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other