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

Model Number NM-401L-0425

Device Problem Ejection Problem (4009)

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

Event Date 11/03/2021

Event Type  malfunction  

Manufacturer Narrative

In speaking with olympus technical assistance, the olympus sales representative stated the devices would be returned for evaluation.The subject device has been received and is currently in the evaluation process.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.However, if additional information becomes available this report will be supplemented accordingly.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

The olympus representative reported on behalf of the customer, the new single use injector needle failed during priming.The needle would inject while in the sheath but not outside the sheath.The issue occurred at the beginning of a therapeutic flexible laryngoscopy with therapeutic kenalog injection to subglottis procedure.No other devices were involved in the event and the intended procedure was completed with a different needle from an ear, nose, and throat (ent) office.No surgical delay.The issue occurred with three (3) new needles.The packages for the needles were intact, opened and made ready for use.No patient harm reported.This complaint is related to patient identifiers: (b)(6).

Manufacturer Narrative

This supplemental report is being submitted to provide additional information based on the device evaluation results conducted by the olympus local service center and to provide additional information based on the legal manufacturer¿s investigation.The device was returned to olympus for evaluation and the issue was confirmed.The inner needle tubing of the used device appeared to be buckled inside the handle which had contributed to the reported complaint.A total of thirteen (13) single use injector forcemax needles (one (1) used and twelve (12) brand new devices with same model nm-401l-0425 and lot number 11v 18 were returned).Two (2) opened pouches had "bad" handwritten on them, but only one (1) used device was returned.Visual inspection found no crack around the injection port.The slider could extend or retract the needle smoothly.When using a test syringe to inject water into the injection port, fluid was able to expel out when the needle was in the sheath, but when the needle was out of the sheath, the fluid would not flow.There was no water leak from the tube sheath during water injection.In addition, seven (7) new injectors were inspected and passed the inspection as they would inject and expel water while needles outside of the tubing.The legal manufacturer reviewed the device history record (dhr) and no abnormalities detected during the manufacturing of the device.The device instruction manual contains the following descriptions, and it warns against this reported event: ¿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.

• 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: 12916344
• MDR Text Key: 285151565
• Report Number: 8010047-2021-15412
• Device Sequence Number: 1
• Product Code: FBK
• UDI-Device Identifier: 04953170422638
• UDI-Public: 04953170422638
• 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: Nurse
• 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: 12/02/2021
• 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: 11V 18
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/17/2021
• 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
• Patient Sex: Male