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

Model Number MN401L-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 has not yet been returned for evaluation/investigation.Therefore, the root cause of the reported phenomenon could not be determined at this time.Investigation is ongoing.This report will be supplemented accordingly following investigations.

Event Description

It was reported that during a therapeutic procedure, the customer was unable to inject solution when the needle was extended pass the sheaths.The intended procedure was completed with same similar needles from the same box.There was no patient harm or impact reported due to the event.No user injury reported.

Manufacturer Narrative

This report is being supplemented to provide additional information based on customer response and updates.

Event Description

The issue occurred in the beginning of a steroid injection to subglottic stenosis through a flexible, channeled laryngoscope procedure.No harm or injury.Customer opened a new box with a different lot # and had success.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's investigation.The following sections were updated: d4,d9, g3, g6, h2, h3,h4, h6 and h10.A review of the device history record for the lot(12v24)found no anomaly with the event-related items.Device evaluation was performed.The lot no.Received was 12v24.Evaluation as follows: ·white foreign residue lodged inside the insertion portion tube.·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 needle did not extend and had very minimal movement.·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 subject device.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, 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: 12153487
• MDR Text Key: 280506148
• Report Number: 8010047-2021-08748
• 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,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 08/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Model Number: MN401L-0623
• Device Lot Number: 12V24
• 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: 08/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1