MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE INJECTOR; INJECTOR AND SHEATHSET

Model Number	NM-401L-0423
Medical Device Problem Codes	Mechanical Problem (1384); No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device was received and evaluated.Device inspection and evaluation found the customer reported issue was replicated.Visual inspection on the received condition was performed and noted yellowish foreign residue lodged inside the insertion portion tube.The yellowish residue inside of the tube at the distal end.The handle section appears normal, and the needle was fully retracted upon received.The device was not received with the original packaging.A functional inspection was performed on the device.Functional testing was performed by fully extended and retracted the needle out of the sheath without using excessive force.The injection inspection was tested by filling a syringe with water and attaching it to the injection port.Once attached, it was attempted to test the injection of fluid in both pushed and pulled directions.During testing , the needle was extended from the distal end side of the insertion portion and was unable to inject fluid when the needle was extended.It was attempted to apply more force to the syringe and the outcome was the same.However, fluid from the syringe was able pass through when in a pulled position.Based on device evaluation , the customer reported issue was replicated.Investigation is ongoing.This report will be supplemented accordingly following investigation.
Event or Problem Description
It was reported that during a gastric endoscopy therapeutic procedure, when the needle was "out" they could not inject, when the needle was "in" they could inject.The intended procedure however, was able to be completed.According to the reporter, it delayed the procedure momentarily but did not impact the outcome of the procedure.There was no patient harm or injury reported due to the event.No user injury was reported.Device evaluation found unable to inject fluid when needle was extended, however, fluid from the syringe was able to pass through when in a pulled position.The reported customer issue was replicated.This report is being submitted for unable to inject fluid when needle was extended found during device evaluation.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 1 year since the subject device was manufactured.Based on the results of the investigation, it is likely that this phenomenon occurred due to the compressive bucking on the needle tube.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.·angle of the distal end of the endoscope a definitive root cause cannot be identified.The instructions for use (ifu) instruction manual state: ¿- ifu warns against this event as follows: ·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 the field performance of this device.Correction to g3 of the initial medwatch.The aware date should be 23-nov-2021.

• Brand Name: SINGLE USE INJECTOR
• Common Device Name: INJECTOR AND SHEATHSET
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 13691483
• Report Number: 8010047-2022-04070
• Device Sequence Number: 19319008
• Product Code: FBK
• UDI-Device Identifier: 04953170422621
• UDI-Public: 04953170422621
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2022

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: 07V 20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2022
• 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: 02/09/2022
• Supplement Date Received by Manufacturer: 06/01/2022
• Initial Report FDA Received Date: 03/08/2022
• Supplement Report FDA Received Date: 06/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/19/2020
• 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