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

Model Number NM-401L-0623

Device Problem Defective Device (2588)

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

Event Date 09/20/2021

Event Type  malfunction  

Manufacturer Narrative

The subject device has not yet been received for evaluation.The cause of the issue cannot be determined at this time.Investigation is ongoing.This report will be supplemented accordingly following investigation.

Event Description

As reported, the customer have experienced 3 (three) injectorforcemax model no.Nm-401l-0623 needle failures.The same scenario, when the needle is extended outside the shaft unable to inject the fluid.The initial prime of the needle is fine.The issue occurred during an unspecified procedure.The customer stated the first 3 needles that was used had the same issue and did not worked.The fourth needle from the same box worked as expected and the intended procedure was completed with no harm or injury to the patient.There was no user injury reported.Customer did not provide the lot number of the needle used to complete the procedure.This report is related to reports with patient identifier (b)(6), (b)(6).

Manufacturer Narrative

This report is being supplemented to provide additional information based on customer follow up and updates.Further communication with the customer conveyed the following information: customer stated that there are 2 needles failed on (b)(6) 2021.The two needles were used in one case, same patient.The 2 needles failed and the 3rd one used completed the procedure.No patient injury, no user injury.Customer stated that the 2 needles used on the same procedure are being returned however, a third needle is also being returned and was not used.Customer stated that they do not trust the needle so it will be returned.She will return total of 3 needles.To date the subject device has not yet been received for evaluation.Investigation is ongoing.This report will be supplemented accordingly following investigation.

Event Description

Updates on event reported.Two needles failed during the procedure.The third needle was used to complete the case.

Manufacturer Narrative

This report is being supplemented to provide h4.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the device evaluation and the legal manufacturer's final investigation.Device evaluation confirmed the customer's complaint.A visual inspection on the received condition and noted white foreign residue lodged inside the insertion portion tube.The white residue inside of the tube is in various sections throughout.Upon testing the actual device, white foreign residue began to expel out the distal end.A review of the device history record found no deviations that could have caused or contributed to the reported issue.The device met all specifications at the time of shipment.Based on the results of the investigation, it is likely that the tube became lodged due to white foreign residue which caused the liquid not to flow in the tube.The white foreign residue might have gotten into the tube due to handling of the device at the facility.A bending force might have been applied to the tube when the device was inserted into the endoscope, removed from the sterile package or during pre-inspection.This might have caused the tube to buckle.The specific root cause could not be determined at this time.The following information is stated in the instructions for use which may have prevented the event: "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.

• 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: 12544422
• MDR Text Key: 278136770
• Report Number: 8010047-2021-12410
• Device Sequence Number: 1
• Product Code: FBK
• UDI-Device Identifier: 04953170422669
• UDI-Public: 04953170422669
• 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,Followup,Followup
• Report Date: 04/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Model Number: NM-401L-0623
• Device Lot Number: 12V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/24/2021
• 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