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

Model Number	NM-401L-0525
Medical Device Problem Code	Failure to Discharge (1169)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that the injector and sheath set were unable to inject liquid.The issue occurred during a diagnostic procedure; however, the procedure was completed.There were no reports of patient harm.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of 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.The device was returned to olympus for inspection, and the reportable malfunction was confirmed.A definitive root cause was not identified, however, based on the results of the investigation, the probable cause of the malfunction (unable to extend needle) would likely be an increase in frictional resistance between the outer tube and the needle tube, possibly caused by tube bending due to physical stress during procedures such as insertion into an endoscope, removal from the sterilization package, or during pre-use inspection.For the malfunction (unable to inject liquid into the target tissue), the probable cause would be compressive buckling on the needle tube, likely due to high friction between the outer tube and the needle, exacerbated by factors such as abrupt slider movement, coiling of the tube during inspection, and kinks in the tube.The event can be prevented by following the instructions for use which state: (rk1555 rev02).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: 19739883
• Report Number: 9614641-2024-01431
• Device Sequence Number: 3642010
• Product Code: FBK
• UDI-Device Identifier: 04953170422652
• UDI-Public: 04953170422652
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2024

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-0525
• Device Lot Number: 38V29
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 06/27/2024
• Supplement Date Received by Manufacturer: 08/01/2024
• Initial Report FDA Received Date: 07/15/2024
• Supplement Report FDA Received Date: 08/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/29/2023
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown