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

Model Number	NM-401L-0423
Medical Device Problem Codes	Failure to Infuse (2340); No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Address-full address name of the facility - (b)(6).The subject device was received and evaluated.Device evaluation found the tube sheath was kinked.Device evaluation is still in progress and the final complete evaluation results has not yet been provided.Investigation is ongoing.This report will be supplemented accordingly following investigation.
Event or Problem Description
It was reported at preparation for use (before procedure) for a therapeutic gastric ulcer (bleeding case), the nurse inspected, test the injector and found no problem.However, during the procedure, when the injector (with needle out) was inside the scope, the nurse injects the adrenaline solution and the solution were stuck and cannot flow through the lumen despite trying for many times.The nurse tried to examine and test the injector after taking it out from the scope, however, the same issue transpired.A second injector was opened and was used to continue the procedure.The intended procedure was completed using a similar device and the patient was reported to be in good status.There was no patient harm, no user injury reported due to the event.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the approved final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the definitive root cause of the kinked tube sheath could not be determined.Olympus will continue to monitor field performance for this device.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 friction between the outer tube and the needle may have increased due to the needle having been extended or retracted while the tube was coiled in inspection of operation, the slider being abruptly pushed, the angle of the endoscope¿s distal end, or the tube kink.A bending force might have been applied to the tube when the device was withdrawn from the endoscope, removed from the sterile package or during pre-inspection.This might have caused the tube to buckle.The instruction manual identifies the following verbiage, which may have prevented the phenomenon: ¿do not coil the insertion portion with a diameter of less than 15 cm.This could damage the insertion portion.Use care when operating the nm-401 series.Otherwise, the insertion portion could be damaged.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: 16192693
• Report Number: 9614641-2023-00076
• Device Sequence Number: 4284973
• Product Code: FBK
• UDI-Device Identifier: 04953170422621
• UDI-Public: 04953170422621
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2023

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: K2307
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2023
• 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: 12/21/2022
• Supplement Date Received by Manufacturer: 04/12/2023
• Initial Report FDA Received Date: 01/18/2023
• Supplement Report FDA Received Date: 05/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/06/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ADRENALINE SOLUTION SCOPE
• Patient Sex: Unknown