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

Model Number	NM-401L-0423
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported, the single use injector had very strong resistance at the syringe and would not inject the solution at all through the syringe.The issue occurred during a product demonstration.There were no reports of patient harm.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the device evaluation and 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.It has been over (2) years since the subject device was manufactured.Based on the results of the investigation, it was likely that the phenomenon ¿unable to inject liquid into the target tissue¿ occurred due to the compressive bucking on the needle tube.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.It was likely that the friction between the outer tube and the needle increased by the following factors.The needle extended/retracted while the tube was coiled in inspection of operation.The slider was abruptly pushed.Angle of the distal end of the endoscope.The tube was kinked.A bending force might have been applied to the tube when the device was pull out the endoscope, removed from the sterile package or during pre-inspection.This might have caused the tube to buckle.However, the root cause could not be determined.The instruction manual contains the following descriptions, and it warns against this event."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." 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: 19566823
• Report Number: 9614641-2024-01284
• Device Sequence Number: 6974384
• Product Code: FBK
• UDI-Device Identifier: 04953170260018
• UDI-Public: 04953170260018
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2024

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: 24K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2024
• 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: 06/11/2024
• Supplement Date Received by Manufacturer: 07/16/2024
• Initial Report FDA Received Date: 06/19/2024
• Supplement Report FDA Received Date: 07/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/28/2022
• 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