MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE INJECTOR; INJECTOR AND SHEATHSET

Model Number NM-400U-0425

Device Problems Failure to Deliver (2338); Failure to Infuse (2340); Infusion or Flow Problem (2964)

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

Event Date 12/20/2022

Event Type  malfunction  

Manufacturer Narrative

The subject device has not yet been received for evaluation.The cause of the issue cannot be determined at this time.Investigation is ongoing.This report will be supplemented accordingly following investigation.

Event Description

User facility reported with an issue of "ink spreads".Customer stated "the ink is spreading everywhere except where the ink needs to go.According to the reporter, the issue occurred during a standard procedure for a diagnostic colonoscopy procedure.The intended procedure was completed using a similar device.No harm was reported.No patient harm, no user injury reported.This event includes 3 reports: report with patient identifier (b)(6) (nm-400u-0425 lot 1yv).Report with patient identifier (b)(6) (nm-400u-0425 lot 1zv).Report with patient identifier (b)(6) (nm-400u-0425 lot 07v 20).This report is for report with patient identifier (b)(6) (nm-400u-0425 lot 1yv).

Manufacturer Narrative

This report is being supplemented to provide additional information based on the approved final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, and the device was not returned for evaluation, the definitive root cause of the reported issue could not be determined.The device was manufactured in november 2021, but the exact date is unknown.The instruction manual identifies the following verbiage, which may have prevented the phenomenon: ¿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.¿ olympus will continue to monitor field performance for this device.

• Brand Name: SINGLE USE INJECTOR
• Type of Device: INJECTOR AND SHEATHSET
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer (Section G): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16191993
• MDR Text Key: 307576577
• Report Number: 9614641-2023-00074
• Device Sequence Number: 1
• Product Code: FBK
• UDI-Device Identifier: 04953170422577
• UDI-Public: 04953170422577
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NM-400U-0425
• Device Lot Number: 1YV
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2021
• 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