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

Model Number	NM-401L-0423
Medical Device Problem Code	Failure to Deliver (2338)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: establishment name: (b)(6).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 single-use injector was unable to inject liquid after being extended.Attempted to withdraw the needle to exit the scope and was unable to retrieve it.The issue occurred, during a therapeutic esophageal stent implantation procedure.Which was completed using a similar device.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.Corrected fields: d8.Additional information added to field h4 and h6.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 3-digit lot number provided, the manufacturing date of the device was in the month of august 2022 but a specific date could not be identified.Based on the results of the investigation, it is likely that this phenomenon occurred due to the compressive bucking on the needle tube.Therefore, 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.A definitive root cause cannot be identified.The following is included in the instructions for use (ifu): 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
• 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: 20032997
• Report Number: 9614641-2024-01676
• Device Sequence Number: 6536962
• Product Code: FBK
• UDI-Device Identifier: 04953170260018
• UDI-Public: 04953170260018
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K902736
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2024

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: 28K
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2024
• Supplement Date Received by Manufacturer: 09/13/2024
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 09/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/01/2022
• 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