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

Model Number NM-401L-0425

Device Problem Obstruction of Flow (2423)

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

Event Date 11/29/2021

Event Type  malfunction  

Manufacturer Narrative

As the suspect device has not been received by olympus for evaluation, a root cause for the reported event cannot be determined.If additional information becomes available or the device is returned for evaluation, a supplemental report will be submitted.

Event Description

An olympus representative was informed by the user facility of a report that, upon deployment of the olympus, model nm-401l-0425 single use injector, it failed to dispel fluid; "it got jammed." the problem caused a delay in procedure of a few seconds while a new package was opened; there was no adverse health effect to the patient attributed to the delay.The intended procedure is unknown but it was reported that it was likely a "botox" procedure.The intended procedure was completed with another needle.There was no patient injury, associated with the problem, reported to olympus.This is report #2 of 2 due to multiple devices reported.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information based on the evaluation results on the returned device, and legal manufacturer¿s investigation.The customer returned 2 injector needles, model nm-401l-0425 with the same lot# 07v 07 for evaluation.Please cross reference c21471024 for device #1: the injector (subject device) was received with needle retracted inside, and intact.There is no biomaterial inside the tubing, and no abnormality on the entire tube sheath.The handle appeared to be normal as the slider could extend or retract needle smoothly.Observed that when using a test syringe to inject water into the injection port, fluid was able to expel out when the needle was inside the tube sheath, but fluid would not flow when needle extended outside the tube sheath.No water leakage from the tube sheath during water injection.Further troubleshooting, the slider was disassembled, and found the needle tube to be kinked at the handle boot area which could have contributed to the reported complaint.The legal manufacturer reviewed the device history record (dhr) and no abnormalities detected during the manufacturing of the device.There were no abnormalities detected in the dhr for the following items, which is related to the reported phenomenon: needle extension and retraction, extended length of needle, no bent/kink/crack/scratch on the tube, and injection of the liquid.The device instruction manual contains the following descriptions, and it warns against this reported event (gk6631 rev10): ¿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 the biopsy valve, and keep it as straight as possible relative to biopsy valve.Otherwise, the instrument could be damaged.Insert the instrument slowly.Abrupt insertion could damage the endoscope 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.¿ a review of similar reported 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.·the kink of the tube.·angle of the distal end of the endoscope although, the subject device was not returned the factory for evaluation, it is possible to infer that the cause of the previous complaint is also similar based on the investigation conducted by the legal manufacturer.

• 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: 13060811
• MDR Text Key: 286429384
• Report Number: 8010047-2021-16635
• Device Sequence Number: 1
• Product Code: FBK
• UDI-Device Identifier: 04953170260070
• UDI-Public: 04953170260070
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K902736
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 04/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NM-401L-0425
• Device Lot Number: 07V 07
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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