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

Model Number	NM-401L-0623
Medical Device Problem Codes	Mechanical Problem (1384); No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation result: the model number nm-401l-0623 was received for evaluation.The lot number was 16v with supplementary information number of ¿18¿.(m-bc manufacture date: june 18, 2021).Device evaluation , the following noted : the needle could extend from the outer tube.It was not possible to inject liquid when the slider was pushed.However, it was possible to inject liquid when the slider was pulled.The outer tube was not buckled.The needle tube presented compressive buckling.No other abnormalities that could lead to the phenomenon of the reported event could not be confirmed.The dhrs (device history records) for this product have been reviewed.No abnormalities were detected in the device history record with the lot number for the following inspection items which related to the reported phenomenon.Process inspection sheet.Quality inspection sheet.Nonconforming product report.Ifu (instruction for use) : the instruction manual contains the following descriptions, and it warns against this event.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.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.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.Conclusion : it is determined that liquid could not be injected due to compressive buckling of the needle tube.Since friction resistance between the outer tube and needle tube has increased, compressive buckling might have occurred when the needle was extended.A likely mechanism causing friction resistance between outer tube and needle tube might be the following: the tube was coiled during the inspection for operation.Olympus will continue to monitor complaints for this device.
Event or Problem Description
As reported, a problem has occurred with the sample product (demo product).The doctor inserted it into the forceps channel and tried to inject the drug solution (kenacort) locally, but the injection amount was too heavy to inject.User tried to see if the drug solution came out even outside the body cavity but it did not.The device was replaced.The intended procedure (vocal cord steroid injection (therapeutic) was completed with a similar device.There was no patient harm, no user injury reported due to the event.According to the reporter, the device was inspected prior to use, no problem found during the preoperative injection check.This report is being submitted for injection needle malfunctions, problem of puncture / problems of delivering liquid.Unable to inject liquid.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information.Olympus will continue to monitor the field performance of this device.

• Brand Name: SINGLE USE INJECTOR
• Common Device Name: INJECTOR AND SHEATHSET
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer Contact: masaharu hirose ; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0-357 ; JA 036-0357 ; 426422891
• MDR Report Key: 15095283
• Report Number: 9614641-2022-00028
• Device Sequence Number: 20132990
• Product Code: FBK
• UDI-Device Identifier: 04953170422669
• UDI-Public: 04953170422669
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K902736
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: NM-401L-0623
• Device Lot Number: 16V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2022
• Supplement Date Received by Manufacturer: 07/26/2022
• Initial Report FDA Received Date: 07/25/2022
• Supplement Report FDA Received Date: 08/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/17/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SCOPEKENACORT
• Patient Sex: Unknown