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 Type  malfunction  

Event Description

User facility reported with an issue of "ink spread everywhere except desired location".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.Per the report , the problem occurred/failed twice on the same model with the same lot (21v).No further information provided.This event includes two (2 ) reports to capture the two reported failure: report with patient identifier (b)(6) (nm-400u-0425, lot 21v).Report with patient identifier (b)(6) (nm-400u-0425, lot 21v).This report being submitted is for report with patient identifier (b)(6) (nm-400u-0425, lot 21v).

Manufacturer Narrative

The customer returned unused brand new quantity of (10) of the same model and of the same lot.The used device (subject device) reported to be failed was not returned evaluation.Investigations ongoing.This report will be supplemented accordingly following investigation.

Manufacturer Narrative

This report is being supplemented to provide additional information based on customer response to follow up , evaluation results of brand new unused lot 21v returned by the customer and the legal manufacturer's final investigation.Additionally, correction on d9 from the initial report, d9 was updated from yes to no.Follow up communication with the customer, confirmed that 2 lots were failed (21v) during a case however, it will not be returned as it was disposed.However, customer returned 10 unused (brand new) lot 21v and was received at service business center olympus san jose center.The unused 21v lot (4 lots out of 10 returned) were tested.Two (2) out of the four (4) lots were tested under the related patient identifier (b)(6).Visual inspection of the returned unused devices did not find any signs of kinks/dents/damage to the insertion portion sheath of devices when received for inspection.Functional testing performed and found no issues with the water streamline flow for both devices when the plunger of the test syringe was fully pressed.The stream line water flow was in a straight position and not spreading out for both devices.In addition, the needle extends/withdraw fully from the distal end side when the slider was manipulated.Device evaluation found no issues.Legal manufacturer investigation: a review of the device history record found no deviations that could have caused or contributed to the reported issue.All records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.The instruction manual contains the following descriptions, and it warns against this event.(rk1556 rev.02) 4.User qualifications the operator of this instrument must be a physician or medical personnel under the supervision of a physician and must have received sufficient training in clinical endoscopic technique.This manual does not explain or discuss clinical endoscopic procedures.¿before use, prepare and inspect the instrument as instructed below.Should 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.Conclusion summary: the root cause of the reported event could not be identified.Based on the following, it is determined that there were no abnormalities in the device.·the evaluation result of the returned unused device showed that there were no abnormalities in the new product during the functional testing.·review of dhr found no abnormalities.It is probable that due to factors such as condition of the body tissue or angle of the needle when puncturing the body tissue, the ink possibly had spread to non-targeted area.However, the exact cause of the reported event could not be determined.Olympus will continue to monitor complaints 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: 16218469
• MDR Text Key: 309300697
• Report Number: 9614641-2023-00094
• 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: 02/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2023
• 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: 21V
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/20/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/22/2021
• 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