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

Model Number NM-401L-0423

Device Problem Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/21/2022

Event Type  malfunction  

Manufacturer Narrative

Address: full address of the customer facility is (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: k1323.·needle can be retracted, but not able to be extended (jammed), kink found on outer tube.·tested cannot inject fluid when needle in retracted position.·tested cannot inject fluid 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.From evaluation results and a similar complaint in the past, it was likely that the phenomenon occurred due to the compressive bucking on the needle tube.It is unlikely a unit with defective needle is shipped as nm-401l series undergo 100% inspection for appearance, needle operation and injection.Therefore 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.·angle of the distal end of the endoscope ·kink of the tube a bending force might have been applied to the tube when the device was inserted into the endoscope, removed from the sterile package or during pre-inspection.This might have caused the tube to buckle.Olympus will continue to monitor complaints for this device.

Event 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 (3) injection needle on the same lot (lot no.13k).This report is for the third injection needle.This report is related to a report with patient identifier (b)(6) (first injection needle unit ) and (b)(6) (second injection needle unit).

Manufacturer Narrative

Correction to h6 investigation conclusion.Additional information: h4 - udi added.This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A definitive root cause cannot be identified.Olympus will continue to monitor the field performance of this device.

• Brand Name: SINGLE USE INJECTOR
• Type of Device: 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: 14460417
• MDR Text Key: 300342305
• Report Number: 8010047-2022-08616
• Device Sequence Number: 1
• Product Code: FBK
• UDI-Device Identifier: 04953170422621
• UDI-Public: 04953170422621
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: K902736
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 07/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 06/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/23/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SCOPE