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

Model Number NM-401L-0623

Device Problems Filling Problem (1233); Defective Device (2588)

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

Event Date 06/14/2021

Event Type  malfunction  

Manufacturer Narrative

The subject device was received and evaluated.Visual inspection on the received condition was performed.White foreign residue lodged inside the insertion portion tube was observed.The white residue inside of the tube is in various sections throughout.The handle section appears normal, and the needle was fully retracted upon being received.The device was received with the original packaging that was already open prior to receipt.A functional inspection was also performed.Functional testing attempted to extend the needle out of the sheath by pushing the slider into the holder portion; however, the needle did not extend and had very minimal movement.Further, the injection inspection was tested by filling a syringe with water and attaching it to the injection port.The water was injected, and initially the movement from the syringe was restricted.As soon as more force was applied to the syringe, white foreign residue began to expel out the distal end.Once all the white foreign residue was removed, the fluid flowed normal through the complaint device.Investigation is ongoing.This report will be supplemented accordingly following investigations.

Event Description

It was reported that during preparation for use for a therapeutic steroid injection to subglottic stenosis procedure, the device had an issue during priming.The device was replaced with similar device from the same box and the intended procedure was completed.There was no patient harm or impact reported due this event.No user injury reported.This event reported is related to report with patient identifier (b)(6).

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's investigation.The following sections were updated: g3, g6, h2, h6 and h10.Based on the results of the investigation, it can be inferred that the tube became lodged due to white foreign residue.Therefore, the liquid did not flow in the tube.Since no abnormalities detected in the dhr (device history record), the white foreign residue might have gotten into the tube due to handling of the device at the facility.The instruction manual contains the following descriptions, and it warns against this event.(rk1556 rev.01) before use, prepare and inspect the instrument as instructed below.Should the any irregularity be observed, do not use the instrument; use a spare instead.Damage or irregularity may compromise patient or user safety, for example: posing an infection-control risk, causing tissue irritation, perforation, bleeding or mucous membrane damage, and may result in more severe equipment damage.·be sure to use a fluid intended for patient use when inspecting injection.If other fluids are used, the fluids may remain in the instrument.This could pose an infection-control risk or cause tissue irritation.Olympus will continue to monitor complaints for 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
• MDR Report Key: 12340237
• MDR Text Key: 267516286
• Report Number: 8010047-2021-10431
• Device Sequence Number: 1
• Product Code: FBK
• UDI-Device Identifier: 04953170422669
• UDI-Public: 04953170422669
• Combination Product (y/n): N
• PMA/PMN Number: K902736
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NM-401L-0623
• Device Lot Number: 12V 24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1