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); Failure to Infuse (2340)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Device evaluation and inspection, noted needle can be retracted however it become stuck and unable to extend.Still possible to inject fluid (no blockage).Fluid remained inside.Internally soiled.Investigation is ongoing.This report will be supplemented accordingly following investigation.
Event or Problem Description
As reported, before the procedure the nurse inspects the injector and use the adrenaline solution to test the injection and there was 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 got stuck and cannot flow through the lumen despite trying for many times.The nurse has also tried to examine and test the injector after taking it out from the scope, but the same issue transpired.Therefore, a second injector was opened and used to continue the procedure.The intended procedure (bleeding case gastric ulcer) was completed by using another similar injection needle.There was no patient harm or injury reported due to the event.No user injury reported.This report is for the first injection needle unit lot ozk.This report is related to a report with patient identifier (b)(6) (second injection needle unit) lot 16k.
Additional Manufacturer Narrative
This report is being supplemented to provide a correction and additional information based on the legal manufacturer¿s final investigation.New information was added to the following fields: d4, h6, h10.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 most probable cause was due to compressive buckling of the needle tube.This likely occurred 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 the event can be detected/prevented by following the instructions for use which states: ·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 of this device.

• 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: 14839133
• Report Number: 8010047-2022-10889
• Device Sequence Number: 11358491
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2022

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: 0ZK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2022
• 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: 05/31/2022
• Supplement Date Received by Manufacturer: 07/01/2022
• Initial Report FDA Received Date: 06/28/2022
• Supplement Report FDA Received Date: 07/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/15/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SCOPE.
• Patient Sex: Unknown