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

Model Number NM-400U-0423

Device Problem Difficult to Remove (1528)

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

Event Date 03/31/2023

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned for evaluation.If additional information becomes available prior to the conclusion of the investigation, a supplemental report will be filed.

Event Description

The customer reported that his olympus single-use injector was experiencing removal difficulty during a colon tattooing for a surgical resection.According to the initial reporter, the device was inspected prior to use and no abnormalities were noted.However, during the procedure, while the injector was inside the scope, the nurse injected the color dye and the solution got stuck and could not flow through the lumen.Reportedly, the nurse attempted several times and eventually the needle could not be retracted and deployed.The physician was ultimately able to complete the procedure, without patient harm, by using another injector.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.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, the tube sheath was kinked, the needle was unable to be retracted and extended, and color dye remained along the tube.However, definitive root cause of the kinked tube sheath could not be determined.It is likely that the injection failure occurred due to the needle tube having been buckled, and the lumen narrowed.Additionally, a bending force might have been applied to the tube when the device was inserted into the endoscope, removed from the sterile package or during pre-inspection.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.Straighten out the instrument before inspecting it.The instrument can be damaged if it is coiled while the handle is operated.Do not coil the insertion portion with a diameter of less than 15 cm.This could damage the insertion portion.Before use, confirm that the needle and the insertion portion are not damaged.If any abnormalities such as significant deformations or excessive bends are found, do not use the instrument.Otherwise, it may cause perforation, bleeding, mucous membrane damage.Confirm that the needle extends in the endoscopic image are normal.If any abnormalities are found, do not use the instrument.Otherwise, it may cause perforation, bleeding or mucous membrane damage.When inserting the instrument into the endoscope, retract the needle into the tube, hold the instrument close to the biopsy valve, and keep it as straight as possible relative to the biopsy valve.Otherwise, the instrument could be damaged.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.Do not push the slider abruptly, otherwise the needle will be rapidly extended from the distal end of the tube.This could result in patient injury, such as perforation, bleeding or mucous membrane damage.It could also damage the instrument.¿ 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: 17058694
• MDR Text Key: 317226256
• Report Number: 9614641-2023-00786
• Device Sequence Number: 1
• Product Code: FBK
• UDI-Device Identifier: 04953170259876
• UDI-Public: 04953170259876
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: K902736
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NM-400U-0423
• Device Lot Number: 2YK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/10/2022
• 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