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	10/24/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported to olympus, the single use injector could not deliver the liquid to the target tissue during an endoscopic mucosal resection (emr) procedure.The procedure was completed by replacing with a similar product and there was no delay in the procedure.There were no reports of patient harm associated with the event.
Additional Manufacturer Narrative
The device was returned.Based on investigation results, it is determined that liquid could not be injected due to compressive buckling of the needle tube.Since friction resistance between the outer tube and needle tube has increased, compressive buckling might have occurred when the needle was extended.A likely mechanism causing friction resistance between outer tube and needle tube might be the following: the tube was coiled during the inspection for operation.The root cause of this event was unable to be identified.A review of the device history record found no deviations that could have caused or contributed to the reported issue.No complaint trend abnormalities were detected in the quality data analysis of the event.The event can be 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.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer Contact: masaharu hirose ; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0-357 ; JA 036-0357 ; 426422891
• MDR Report Key: 15826051
• Report Number: 9614641-2022-00640
• Device Sequence Number: 6005057
• Product Code: FBK
• UDI-Device Identifier: 04953170382338
• UDI-Public: 04953170382338
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other,Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/18/2022

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: K7802
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2022
• Initial Report FDA Received Date: 11/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2017
• 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