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

Model Number NM-401L-0525

Device Problem No Flow (2991)

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

Event Date 02/01/2022

Event Type  malfunction  

Event Description

As reported, the ent device was reported to fail upon initial clinical use.The operator connected the nm-401l-0525 single use injector and tried to pass fluid through the needle, could not push any fluid, it was blocked.The customer tried three different injectors from this lot with no success.Customer did not complete the injection part of the case.There was no patient harm or injury reported due to the event.No user injury reported this report is related to report with patient identifier (b)(6) and (b)(6).

Manufacturer Narrative

The subject device was not returned for evaluation.In a follow up communication with the customer representative, it was conveyed that the product was disposed of at the hospital and is not available to be returned.Investigation is ongoing.This report will be supplemented accordingly following investigation.

Manufacturer Narrative

This report is being supplemented to provide additional information based on customers representative response and updates.Investigation is ongoing.This report will be supplemented accordingly following investigation.

Event Description

Updates on event reported based on customer response : further communication with the customer, the following information conveyed: the procedure was a kenalog injection for subglottic stenosis.At the time of injection, they were only able to inject a very small amount of fluid before the devices seemed blocked and they could no longer push any additional fluid through the needles.They were not able to inject the full amount of fluid during the procedure.The patient did not receive a full injection the day of the event.When the procedure was over, the patient was understanding of the situation.The patient has already returned and had a full procedure completed.The patient has recurring procedures scheduled every 4 weeks for the same procedure and has already been back.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device lot number was not received however, the device history records (dhrs) for the past year prior to the aware date of this event were inspected and no abnormalities were found that could have led to the reported event.The age of the device is unknown since the lot number was not received.Based on the results of the investigation, the exact cause could not be conclusively identified since the device was not retuned.However, based on a similar complaint in the past, it is likely that the phenomenon occurred due to the compressive bucking on the needle tube.It is unlikely a unit with defective needle is shipped as nm-401l series undergo 100% inspection for appearance, needle operation and injection.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.It was likely that 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 the instruction manual contains the following descriptions, and it warns against this event.(rk1556 rev.01) ·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.Although the actual defect was not sent, it is possible to infer the cause from the investigation results of similar cases in the past, so it is unnecessary to investigate using the same structure of equipment and similar equipment.It was judged.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: 13654293
• MDR Text Key: 296700379
• Report Number: 8010047-2022-03795
• Device Sequence Number: 1
• Product Code: FBK
• UDI-Device Identifier: 04953170422652
• UDI-Public: 04953170422652
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NM-401L-0525
• Device Lot Number: 1YV
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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