MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE INJECTOR NM600/610; INJECTOR AND SHEATHSET

Model Number NM-610U-0325

Device Problem Failure to Eject (4010)

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

Event Date 02/01/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.Therefore, the root cause of the reported event cannot be determined at this time.However, if additional information becomes available this report will be supplemented accordingly.

Event Description

"the customer reported to olympus that during an endoscopic mucosal resection (emr) the single use injector needle stopped coming out of the sheath during use.The procedure converted to an endoscopic polypectomy and another product was used to complete the case.There was no reported of patient injury due to the event.This complaint requires two reports: (b)(6).This medwatch is for patient identifier: (b)(6).

Manufacturer Narrative

This report is being supplemented to correct and provide additional information as reflected on b5.The suspect device was returned to olympus for evaluation and the allegation was confirmed.When the slider was pressed, the needle would not stick out and the tube was buckling.There were no other abnormalities noted that led to the event reported.A definitive root cause could not be determined.However, based on the results of the device evaluation and the available information, the investigation determined the following likely occurred: 1.) friction resistance increased between the outer tube and the needle tube due to buckling of the tube, causing the reported event.2.) a bending force was possibly applied to the tube when the device was inserted into the endoscope, removed from the sterile package or during pre-inspection, causing the tube to buckle.As a preventive measure, the instructions for use provides the following statements: 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 the 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.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 irregularity such as significant deformations or excessive bends is found, do not use the instrument.Otherwise, it may cause perforation, bleeding, mucous membrane damage.Do not advance or extend the instrument abruptly.This could cause patient injury, such as perforation, bleeding, or mucous membrane damage.It could also damage the endoscope and/or instrument.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.

Event Description

Additional information was received from the olympus representative on behalf of the customer.The issue was found during the therapeutic procedure.There was a delay for an unknown time; however, the patient currently had no problem.This complaint requires two reports under the following patient identifiers for the two devices involved and not for two procedures, as initially reported: (b)(6): needle 1 of 2.(b)(6): needle 2 of 2.

• Brand Name: SINGLE USE INJECTOR NM600/610
• 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: 16482269
• MDR Text Key: 311486217
• Report Number: 9614641-2023-00314
• Device Sequence Number: 1
• Product Code: FBK
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K153625
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NM-610U-0325
• Device Lot Number: 27V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/28/2022
• 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