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

Model Number NM-401L-0425

Device Problem Partial Blockage (1065)

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

Event Date 02/20/2023

Event Type  malfunction  

Event Description

The customer reported to olympus that during preparation for use for a vocal cord injection, the injection needle was clogged, and the liquid could not pass through the single use injector.The therapeutic procedure was completed using a similar injector.There was no patient harm associated with this event.

Manufacturer Narrative

The device was returned to olympus for evaluation.The customer's complaint was confirmed.A visual inspection was performed on the as is received condition of the device; noted it was returned in the original packaging however opened and used.There were no indications of loose or disconnected parts on the needle.Market quality (mq) verified there were no deformations or sharp edges at the distal end.Mq ran fingertips over the entire length of the insertion portion and observed a kink near the handle as well as a kink towards the middle portion.The handle has no signs of cracks or damages on the thread of the injection port.Mq pushed the slider into the holder portion of the needle until it clicked into position to extend the needle from the distal end of the insertion tube with no issues.A test syringe was filled with water and attached to the injection portion.Mq pushed the plunger on the syringe and confirmed that fluid failed to come out of the distal end as heavy restriction was felt.Mq pulled the slider and verified the needle was able to fully retract inside the insertion tube.The ifu warnings and cautions below.Straighten out the instrument before inspecting it.The instrument can be damaged if it is coiled while the handle is operated (2) when inserting the instrument into the endoscope, retract the needle into the sheath, 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 (3) insert the instrument slowly.Abrupt insertion could damage the endoscope and/or instrument (4) 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.Mq confirmed fluid was unable to travel from the injection port through the distal end when test syringe was used.A definitive root cause for this issue was not established.However, it was likely that the phenomenon ¿unable to inject liquid into the target tissue¿ occurred due to the compressive bucking on the needle tube.It is unlikely a unit with defective needle is shipped as nm-401l series undergo 100% inspection for appearance, needle operation and injection.Therefore, the compressive buckling on the needle tube was likely caused when the needle was extended because of the great friction between the outer tube and the needle.It was likely that the friction between the outer tube and the needle increased by the following factors: the needle extended/retracted while the tube was coiled in inspection of operation the slider was abruptly pushed the kink of the tube angle of the distal end of the endoscope.Olympus will continue to monitor field performance for this device.A follow-up with the user facility is currently being performed.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

• 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 036-0 357; JA 036-0357
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16606006
• MDR Text Key: 312317406
• Report Number: 9614641-2023-00419
• Device Sequence Number: 1
• Product Code: FBK
• UDI-Device Identifier: 04953170260070
• UDI-Public: 04953170260070
• 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: Nurse
• Type of Report: Initial
• Report Date: 03/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NM-401L-0425
• Device Lot Number: 11V 15
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/14/2021
• 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