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

Model Number NM-401L-0625

Device Problem Failure to Infuse (2340)

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

Event Date 03/23/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

During an unspecified therapeutic procedure, the user extended the needle through the sheath and then tried to inject medicine through the syringe but nothing came out.A second device, same model and lot number, was used and the same issue occurred.The procedure was aborted.The customer only has one item to return as one of the two devices were discarded.There was no patient death, injury or infection reported.This report is for device 1 of 2.

Manufacturer Narrative

This supplemental report was submitted to provide additional information from the legal manufacturer.The legal manufacturer performed the device history records for this device and all records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.The investigation was completed by the legal manufacturer and determined that there is no manufacturing, material or processing related cause for this failure mode.Based on similar malfunctions, it was likely that the phenomenon occurred due to the compressive bucking on the needle tube when the needle was extended because of the great friction between the outer tube and the needle; 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 as stated on the ifu (instruction for use) and as a preventive measure, the user manual states: - 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 complaints for this device.

Event Description

The doctor at the user facility reported the event occurred during a steroid injection procedure for patient with subglottic stenosis.The device failed when they tried to inject intralesionally.No other devices were replaced during the procedure.There were no patient injuries, but a prolonged procedure and a repeat procedure was required.The instrument was inspected before use for damage, abnormalities, and irregularities.The instrument was also tested, and it worked prior to injection.No device will be returned.

• 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
• MDR Report Key: 11694278
• MDR Text Key: 246286819
• Report Number: 8010047-2021-05155
• Device Sequence Number: 1
• Product Code: FBK
• UDI-Device Identifier: 04953170382383
• UDI-Public: 04953170382383
• Combination Product (y/n): N
• PMA/PMN Number: K902736
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 05/18/2021

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-0625
• Device Lot Number: 96K
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/23/2021
• Initial Date FDA Received: 04/20/2021
• Supplement Dates Manufacturer Received: 05/11/2021
• Supplement Dates FDA Received: 05/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1