MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE INJECTOR; INJECTOR AND SHEATHSET

Model Number NM-401L-0425

Device Problem No Flow (2991)

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

Event Date 01/12/2022

Event Type  malfunction  

Event Description

Customer reported that when the needle was engaged no solution came out of the needle.The issue found during preparation for use for a subglottic kenalog injections and vocal fold injections with botox.The intended procedure was completed using a similar device.There was no patient harm or injury reported due to the event.No user injury reported.This report is related to a report with patient identifier (b)(6).

Manufacturer Narrative

Visual inspection of the device found no abnormalities on the outer sheath.No crack was observed around the injection port, and the needle is straight.The slider could extend or retract the needle smoothly.However, there is trace of fluid and tiny amount of white residues inside tubing consistent with use.Furthermore, when using a test syringe to inject water into the injection port, it was confirmed that fluid was able to expel out when the needle was in the sheath, however, when the needle was out of the sheath that fluid would not flow.There was no water leak from the tube sheath during water injection.Troubleshooting was performed by removing the slider out of its position.The needle tube was found to be kinked about 5mm from the end of the metallic tube.Based on the evaluation findings, the reported complaint of needle engaged but no solution came out of the needle was confirmed due to the damaged needle tube inside.Investigation is ongoing.This report will be supplemented accordingly following completion of investigation.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 1 year since the subject device was manufactured.Based on the results of the investigation, it is likely that this phenomenon occurred due to the compressive bucking on the needle tube.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.A definitive root cause cannot be identified.The instructions for use (ifu) instruction manual state: ¿·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 the field performance of this device.

• Brand Name: SINGLE USE INJECTOR
• Type of Device: INJECTOR AND SHEATHSET
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 13492515
• MDR Text Key: 296305100
• Report Number: 8010047-2022-02646
• Device Sequence Number: 1
• Product Code: FBK
• UDI-Device Identifier: 04953170382345
• UDI-Public: 04953170382345
• 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,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/24/2022

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
• Device Operator: Health Professional
• Device Model Number: NM-401L-0425
• Device Lot Number: 12V 05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/13/2022
• Initial Date FDA Received: 02/09/2022
• Supplement Dates Manufacturer Received: 06/02/2022
• Supplement Dates FDA Received: 06/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/04/2021
• 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