MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD SINGLE USE INJECTOR; INJECTOR AND SHEATHSET

Model Number NM-401L-0425

Device Problems Mechanical Problem (1384); No Flow (2991)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/22/2022

Event Type  malfunction  

Event Description

It was reported during a therapeutic upper endoscopic mucosal resection, during the operation, the needle could not be protruded and the liquid could not be delivered to the tissue.The device was replaced (with the same model ), however, the same problem occurred.The intended procedure, according to the reporter was completed using other company's (third party) product.Customer also stated that the subject device was inspected before use and noted " when the needle was not protruded during the pre-use inspection, the liquid was delivered without any problems, but when the needle was protruded during surgery, the liquid was not delivered ".There was no patient harm, no adverse event reported due to the event.No user injury reported.This event includes two (2) reports (for the two injector needle that failed during the operation) report with patient identifier (b)(6) ( nm-401l-0425 , lot 98k, 1 of 2 ).Report with patient identifier (b)(6) ( nm-401l-0425 , lot 98k, 2 of 2 ).This report is for report with patient identifier (b)(6) ( nm-401l-0425 , lot 98k, 1 of 2 ).

Manufacturer Narrative

Investigation result: the customer returned total of 4 devices: following devices were returned for evaluation/investigation.Defective device:1pc.Un-used/un-opened device:3pcs.One of the two defect devices not returned due to the facility disposed the device.The model number was nm-401l-0425.The lot number was k9808 (manufacturing lot number with manufacturing date), the lot number is 98k.(manufacturing date: (b)(6) 2019.Device evaluation as follows: evaluation of used (claimed defective device ) : the needle could extend from the outer tube.It was not possible to inject liquid when the slider was pushed.However, it was possible to inject liquid when the slider was pulled.The outer tube was not buckled, however, the needle tube presented compressive buckling.No other abnormalities found that could lead to the phenomenon of the reported event.Evaluation of unused device(3pcs): the needles could extend from the outer tube.It was possible to inject liquid when the slider was pushed.The outer tubes were not kinked.The needle tubes have no compressive buckling.No abnormalities observed on the three (3) unused devices.The dhrs (device history records) have been reviewed.No abnormalities were detected in the device history record with the lot number for the following inspection items, which related to the reported phenomenon.The record review includes the following.Process inspection sheet.Quality inspection sheet.Nonconforming product report.Instruction for use (ifu): the instruction manual contains the following descriptions, and it warns against this event.(k6630 rev.11).Straighten out the instrument before inspecting it.The instrument can be damaged if it is coiled while the handle is operated.Operate the slider slowly, otherwise the tube could buckle.Do not coil the insertion portion with a diameter of less than 15 cm.This could damage the insertion portion.When inserting the instrument into the endoscope, retract the needle into the sheath, hold the instrument close to the biopsy valve, and keep it as straight as possible relative to the biopsy valve.Otherwise, the instrument could be damaged.Insert the instrument slowly.Abrupt insertion could damage the endoscope and/or instrument.Stop using the instrument if the insertion portion bends excessively during use.This could result in malfunction, such as failing to extend the needle or inject a fluid.Conclusion summary: for the defective device - it is determined that liquid could not be injected due to compressive buckling of the needle tube.Since friction resistance between the outer tube and needle tube has increased, compressive buckling might have occurred when the needle was extended.A likely mechanism causing friction resistance between outer tube and needle tube might be the following: the tube was coiled during the inspection for operation.The slider was pushed abruptly.Olympus will continue to monitor complaints for this device.

• Brand Name: SINGLE USE INJECTOR
• Type of Device: INJECTOR AND SHEATHSET
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer Contact: masaharu hirose ; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0-357 ; JA 036-0357 ; 426422891
• MDR Report Key: 15637003
• MDR Text Key: 307025014
• Report Number: 9614641-2022-00509
• Device Sequence Number: 1
• Product Code: FBK
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K902736
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NM-401L-0425
• Device Lot Number: 98K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/08/2019
• 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