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

Model Number	NM-221C-0427
Medical Device Problem Code	No Device Output (1435)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was not returned for evaluation and could not be evaluated.Based on the results of the investigation, it is likely failed to inject would have occurred due to the compressive bucking on the needle tube.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.It was likely that the friction between the outer tube and the needle increased by the following factors: ·the needle extended/retracted while the tube was coiled in inspection of operation.·the slider was abruptly pushed.·the kink of the tube.·angle of the distal end of the endoscope.However, a definitive root cause of the reportable issue could not be determined.The subject device was manufactured on september 2023 based on the provided 3 digit lot information.A device history review revealed no issues that could have caused or contributed to the reported issue.This issue is addressed in the instructions for use (ifu): the instruction manual contains the following descriptions, and it warns against this event.¿ 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 the field performance of this device.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported the single use injector failed to inject during the diagnostic cystoscopy procedure as the tubing was kinked.There were no reports of patient harm.

• 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: 19315367
• Report Number: 9614641-2024-01090
• Device Sequence Number: 15206147
• Product Code: FBK
• UDI-Device Identifier: 04953170414978
• UDI-Public: 04953170414978
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• 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: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/14/2024

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-221C-0427
• Device Lot Number: 39K
• Was Device Available for Evaluation?: No
• 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: 01/08/2024
• Initial Report FDA Received Date: 05/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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