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

Model Number NM-401L-0425

Device Problem Infusion or Flow Problem (2964)

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

Event Date 11/02/2022

Event Type  malfunction  

Event Description

It was reported the "nm-401l-0425 needle won't push solution though the syringe when needle is engaged".According to the reporter, this happened twice with this lot number (24v) and with another lot (23v).The intended procedure according to the report was completed.No harm reported , no user injury reported due to the event.Syringe this event includes 3 reports: report with patient identifier (b)(6) (nm-401l-0425 lot 24v).Report with patient identifier (b)(6) (nm-401l-0425 lot 24v).Report with patient identifier (b)(6) (nm-401l-0425 lot 23v).This report is for report with patient identifier (b)(6) (nm-401l-0425 lot 23v).

Manufacturer Narrative

The subject device has not yet been returned for evaluation.The cause of the reported issue is unknown at this time.Follow up is in progress for the device return and gathering additional information regarding the reported event.Supplemental report(s) will be submitted should any relevant new information is available and or received.Investigation is ongoing.This report will be supplemented accordingly following investigation.

Manufacturer Narrative

D4: correction to lot number.H4: the device was manufactured in march 2022, but the specific date cannot be determined.This report is being submitted to provide additional information based on the legal manufacturer¿s final investigation and device evaluation.Three attempts were performed to obtain additional information, but no response was received from the customer.The device was returned without the original packaging.The inspection started at the handle as the slider, injection port and holder appeared normal upon inspection.Olympus also inspected the tube of the insertion portion by running 2 fingers down the entire length and observed crushed/bent section on the tube.Fluid was also found within the tube, but no signs of residue or foreign material was observed.Olympus performed a function check; the needle was able to extends out from the sheath when pushing the slider into the holder portion until the slider clicks into position.Olympus also verified that the needle completely retracted after pulling the slider out until it stops.Olympus confirmed that the slider operated smoothly without having to use any excessive force.In addition, a syringe filled with water was attached to the injection port and was unable to inject fluid from the needle.A review of the device history record (dhr) found no deviations that could have caused or contributed to the observed needle issue "needle won¿t push solution thought the syringe when needle is engaged¿.The dhr confirmed that the subject device was shipped in accordance with the specifications.A definitive root cause for this issue was not established; however, it is probable that the phenomenon ¿unable to inject liquid into the target tissue¿ occurred due to the compressive bucking on the needle tube when the needle was extended due to friction between the outer tube and the needle.It is likely that friction between the outer tube and needle is increased by the following factors: the needle extended/retracted while the tube was coiled in inspection of operation.The slider abruptly pushed.A kink of the tube.Angle of the distal end of the endoscope.The occurrence of the reported problem can be prevented by adhering to the instructions for use (ifu) which states the following: ¿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.¿ ¿straighten out the instrument before inspecting it.The instrument can be damaged if it is coiled while the handle is operated.¿ ¿operate the slider slowly, otherwise the tube could buckle.¿ ¿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.¿ ¿insert the instrument slowly.Abrupt insertion could damage the endoscope and/or instrument.¿ ¿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." olympus will continue to monitor field performance for this device.

Manufacturer Narrative

This report is being supplemented to provide the manufacturing date (h4) and to correct h3 (should be marked yes).The manufacturing date is march 10, 2022 (updated h4).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: 15898772
• MDR Text Key: 308011291
• Report Number: 9614641-2022-00692
• Device Sequence Number: 1
• Product Code: FBK
• UDI-Device Identifier: 04953170422638
• UDI-Public: 04953170422638
• 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: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2022
• 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: 23V 11
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/10/2022
• 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
• Treatment: SYRINGE