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

Model Number NM-401L-0423

Device Problem Mechanical Jam (2983)

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

Event Date 12/29/2022

Event Type  malfunction  

Event Description

The customer reported that a therapeutic gastric ulcer bleeding case was being done.Prior to the procedure, two injectors were opened and inspected by the nurse.No issues were found when the injectors were tested.During the procedure, when the injector, with the needle out, was inside the scope, the nurse injected the adrenaline solution; however, the solution was unable to flow.The solution was stuck and could not flow through the lumen despite multiple attempts.The nurse tried to examine and test the injector after taking it out of the scope, but the same issue occurred.The procedure was completed using another injector.There was no reported patient harm or impact due to this event.

Manufacturer Narrative

Reports are being submitted on both single use injectors used during the procedure.Please refer to the following reports: patient identifier of (b)(6) is related to model number: nm-401l-0423, serial number: (b)(4).Patient identifier of (b)(6) is related to model number: nm-401l-0423, serial number: (b)(4).During device evaluation at olympus, it was found the complaint was confirmed and the tube was kinked.In addition, evaluation found the needle was unable to extend and be retracted (able to inject).This event is under investigation.A supplemental report will be submitted upon receiving additional information.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.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, it was likely that the phenomenon occurred due to the compressive bucking on the needle tube in the handle.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.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: 16276509
• MDR Text Key: 308555940
• Report Number: 9614641-2023-00145
• Device Sequence Number: 1
• Product Code: FBK
• UDI-Device Identifier: 04953170422621
• UDI-Public: 04953170422621
• 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,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2023
• 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 Lot Number: 23K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/06/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1