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

Model Number NM-401L-0423

Device Problems Mechanical Problem (1384); Infusion or Flow Problem (2964)

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

Event Date 12/18/2022

Event Type  malfunction  

Event Description

It was reported at preparation for use (before procedure) for a therapeutic gastric ulcer (bleeding case); the nurse inspected, tested the injector and found no problem.However, during the procedure, when the injector (with needle out) was inside the scope, the nurse injected the adrenaline solution and the solution able to flow, however, for the second time, when the injector (with needle out) was inside the scope, the nurse injects the adrenaline solution and the solution got stuck and cannot flow through the lumen despite trying for many times.Second injector was opened , however, same issue transpired.When the solution was injected, when the injector (with needle out) was inside the scope, the nurse injects the adrenaline solution and the solution able to flow for three times.However, for the fourth time, when the injector (with needle out) was inside the scope, the nurse injects the adrenaline solution and the solution got stuck and cannot flow through the lumen despite trying for many times.The user however, was able to continue the procedure.The intended procedure was completed with no harm reported.The patient was reported to be in good status.No patient harm, no user injury reported due to the event.This event includes two (2 ) reports: report with patient identifier: (b)(6) (first injector).Report with patient identifier: (b)(6) (second injector).This report being submitted is for report with patient identifier: (b)(6) (second injector).

Manufacturer Narrative

Initial reporter name and address: (b)(6).The subject device was received and evaluated.Device evaluation found the tube sheath was kinked.Testing of needle , noted the needle, unable to extend and retracted, unable to inject.Investigation is ongoing.This report will be supplemented accordingly following investigation.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Section d4 was corrected with information that was inadvertently omitted from the initial report.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the definitive root cause of the kinked tube sheath could not be determined.The compressive buckling on the needle tube was likely caused when the needle was extended because of the great friction between the outer tube and the needle.The friction between the outer tube and the needle may have increased due to the needle having been extended or retracted while the tube was coiled in inspection of operation, the slider being abruptly pushed, the angle of the endoscopes distal end, or the tube kink.A bending force might have been applied to the tube when the device was withdrawn from the endoscope, removed from the sterile package or during pre-inspection, which may have caused the tube to buckle.The instruction manual identifies the following verbiage, which may have prevented the phenomenon: ¿do not coil the insertion portion with a diameter of less than 15 cm.This could damage the insertion portion.Use care when operating the nm-401 series.Otherwise, the insertion portion could be damaged.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.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.¿.Olympus will continue to monitor field performance 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 (Section G): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16200448
• MDR Text Key: 309066185
• Report Number: 9614641-2023-00084
• Device Sequence Number: 1
• Product Code: FBK
• UDI-Device Identifier: 04953170454035
• UDI-Public: 04953170454035
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: K902736
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NM-401L-0423
• Device Catalogue Number: N3048440
• Device Lot Number: K2225
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/24/2022
• 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
• Treatment: ADRENALINE SOLUTIONSCOPE