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

Model Number	NM-401L-0423
Medical Device Problem Codes	Failure to Discharge (1169); Failure to Eject (4010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
To date, the device has not been returned.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported, the injector and sheath set was primed however when the doctor tried to inject there was a blockage and the solution couldn¿t be injected.The issue occurred during a therapeutic oesophago-gastro-duodenoscopy (ogd) with sclerotherapy.There were no reports of patient harm.The procedure was completed with another injector and sheath set.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.Additionally, h3, and h6 fields were updated, and the following fields were corrected due to errors in the initial report: h4 (device manufacturer date) and h6 (medical device problem code).A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 3 years since the subject device was manufactured.The device was returned to olympus for inspection, and the customer's complaint was confirmed.The needle could extend from the outer tube, but it was not possible to inject liquid when the slider was pushed as the needle tube was buckled.Based on the results of the investigation, it is likely the failure to inject liquid occurred due to the compressive bucking on the needle tube caused by friction between the outer tube and the needle which may have resulted from the needle being extended/retracted while the tube was coiled during inspection, by the slider being abruptly pushed, or by the angle of the distal end of the endoscope.The issue can be detected/prevented by following the instructions provided in the following: nm-401l-0423 instruction manual, chapter 9 - preparation, inspection and operation section.Caution - straighten out the instrument before inspecting it.The instrument can be damaged if it is coiled while the handle is operated.Caution - operate the slider slowly, otherwise the tube could buckle.Caution - do not coil the insertion portion with a diameter of less than 15 cm.This could damage the insertion portion.Warning - 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.Caution - insert the instrument slowly.Abrupt insertion could damage the endoscope and/or instrument.Caution - 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
• Common Device Name: 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: 18918014
• Report Number: 9614641-2024-00688
• Device Sequence Number: 17849222
• Product Code: FBK
• UDI-Device Identifier: 04953170260018
• UDI-Public: 04953170260018
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K902736
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: NM-401L-0423
• Device Lot Number: 14K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/29/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2024
• Supplement Date Received by Manufacturer: 03/28/2024
• Initial Report FDA Received Date: 03/15/2024
• Supplement Report FDA Received Date: 04/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/22/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown