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

Model Number	NM-221C-0427
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device was not returned to olympus for evaluation due to the single use device being discarded by the customer.A review of the device history record (dhr) found no deviations that could have caused or contributed to the reported malfunction.The dhr confirmed that the subject device was shipped in accordance with the specifications.A definitive root cause could not be determined.The exact cause of the "needle wouldn't go deep enough" could not be conclusively identified, because the device was not returned for evaluation and there were no abnormalities on the device in the device history record.Although the root cause cannot be conclusively identified, based on the investigation result in the past, a likely mechanism causing the reported phenomenon might be the following: probable cause of the failure: the stylet was withdrawn from the needle section before the needle section was inserted into the sheath section.The needle section was inserted into the sheath section with the stylet was being withdrawn from the needle section.The tube of the needle section bent due to a force when the needle section was inserted into the sheath section.The tube was bent.Therefore, a fluid could not inject.The instruction manual contains the following descriptions, and it warns against this event.(rk1157 rev.04).Before use, prepare and inspect the instrument as instructed below.Should any irregularity be observed, do not use the instrument.Use a spare instead.Do not withdraw the stylet before locking the sheath section and the needle section together by positioning the slider at the 1st click stop position.Otherwise the tube could buckle when the needle section is inserted into the sheath section.Operate the slider slowly.Otherwise, the tube could buckle.Be sure to use a fluid intended for patient use when inspecting injection.If other fluids are used, the fluids may remain in the instrument.This could pose an infection control risk or cause tissue irritation.Insert the instrument slowly.Abrupt insertion could damage the endoscope and/or instrument.Do not push in the slider abruptly.The needle may extend abruptly.This could cause patient injury, such as perforations, hemorrhages or mucous membrane damage.Olympus will continue to monitor field performance for this device.
Event or Problem Description
The customer reported to olympus, that they had an out of box failure with the single use injector endoscopic injection needle where the users tried to inject the needle and it would not go deep enough into the target tissue.The issue was found during a therapeutic bladder botox procedure and the procedure was completed with a similar device.There was a delay in the procedure; the procedure was performed with local anesthesia and there was no harm to the patient or user associated with this event.

• 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 036-0 357; JA 036-0357
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17148376
• Report Number: 9614641-2023-00860
• Device Sequence Number: 17537377
• Product Code: FBK
• UDI-Device Identifier: 04953170414978
• UDI-Public: 04953170414978
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K192498
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 06/16/2023

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-221C-0427
• Device Lot Number: 33K
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2023
• Initial Report FDA Received Date: 06/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: FLEXIBLE CYSTOSCOPE
• Patient Sex: Unknown