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

Model Number	NM-401L-0423
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, 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.However; the solution can flow through the lumen when the nurse tests the injector (with needle in).Furthermore, the nurse has also tried to examine and test the injector again after taking it out from the scope, but the same issue transpired.A second injector and third injector were opened and used to continue the procedure but the same issue occurred.The intended procedure (bleeding case gastric ulcer) was completed by using another similar injection needle (needle master, nm-610l-0423 with lot number not provided) and the patient was in a good status.There was no patient harm or injury reported due to the event.No user injury reported.The same issue occurred on three injection needle on the same lot (lot no.13k).This report is for the second injection needle.This report is related to a report with patient identifier (b)(6) (first injection needle unit ) and (b)(6) (third injection needle unit).
Additional Manufacturer Narrative
(b)(6).The subject device lot 13k was received and evaluated.Evaluation results of the service repair noted the following results : the lot no.Indicated on the handle section: k1329.Confirmed needle can be retracted/extended, however no physical defect found.Tested fluid can be injected when needle in retracted position.Tested fluid can be injected when needle in extended position.The dhrs (device history records) for this product have been reviewed.No abnormalities were detected in the device history record with the lot number for the following inspection items which related to the reported phenomenon.The record includes the following.Process inspection sheet, quality inspection sheet, nonconforming product report.The instruction manual contains the following descriptions, and it warns against this event.(gk6631 rev.11) 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.The reported phenomenon could not be replicated.No abnormalities related to the reported phenomenon were confirmed.Therefore, the exact cause of the reported event could not be determined.Although the root cause of this event could not be determined, we will continue to monitor trends and take appropriate actions as necessary.Olympus will continue to monitor complaints for 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: 14460645
• Report Number: 8010047-2022-08617
• Device Sequence Number: 17271931
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2022

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: 13K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2022
• 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: 04/22/2022
• Supplement Date Received by Manufacturer: 06/27/2022
• Initial Report FDA Received Date: 05/20/2022
• Supplement Report FDA Received Date: 07/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/29/2021
• 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