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

Model Number	NM-400U-0423
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was observed that during the device inspection, the single use injector could inject fluid.There was no patient involvement.
Additional Manufacturer Narrative
The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.Corrected fields: e2 and e3.Additional information added to fields: h2, h3, 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 eight (8) months since the subject device was manufactured.Based on the results of the investigation, and for both events, it is likely the following led to the malfunction: -for event 1: it can be inferred that tube bending occurred due to physical bending stress applied to the tube removal from the sterilization package, or during pre-use inspection.-for event 2: it is surmised that 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.The event can be detected and/or prevented by following the instructions for use which state: -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: 19583198
• Report Number: 9614641-2024-01307
• Device Sequence Number: 14287941
• Product Code: FBK
• UDI-Device Identifier: 04953170422560
• UDI-Public: 04953170422560
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2024

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: Other
• Device Model Number: NM-400U-0423
• Device Lot Number: 3YK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2024
• Supplement Date Received by Manufacturer: 07/09/2024
• Initial Report FDA Received Date: 06/21/2024
• Supplement Report FDA Received Date: 07/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2023
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown