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

Model Number NM-401L-0423

Device Problem Mechanical Problem (1384)

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

Event Date 12/09/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The sales representative was informed by the nurse manager at the user facility that the single use injector was reportedly had an out of the box failure as it was unable to inject during an unspecified therapeutic procedure.The procedure was completed with second device from the same lot but it had (unspecified) issues as well.No patient injury or harm was reported.The device will be returned for evaluation.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information based on the evaluation results on the returned device and legal manufacturer¿s investigation.The device was returned to olympus local service center for evaluation.The device was visually inspected to capture the as received condition of the device and found severe kink on the outer tube sheath close to the handle boot.There are biomaterial residues inside the tubing and around the needle, which indicative that the device has been used.The needle appeared to be intact, straight, but retracted inside and would not come out even though the handle slider was manipulated a few times.A test syringe was used to inject the saline solution into the injection port, it was observed that the saline solution would not pass through or expel out.Trouble shooting was performed as the slider was then removed and found the needle tube to be damaged and kinked at about 1cm, which caused the reported phenomenon of ¿unable to inject.¿ the device was not returned to the factory for further evaluation.The legal manufacturer¿s investigation was carried out based on the evaluation conducted by the local service center.The legal manufacturer reviewed the device history record (dhr) and no abnormalities detected during the manufacturing of the device.The device instruction manual contains the following descriptions, and it warns against this reported 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 the biopsy valve, and keep it as straight as possible relative to biopsy valve.Otherwise, the instrument could be damaged.Insert the instrument slowly.Abrupt insertion could damage the endoscope 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.¿ a review of similar reported complaint in the past, it was 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 although, the subject device was not returned to the factory for further evaluation, it is possible to infer that the cause of the previous complaint is also similar based on the investigation conducted by the legal manufacturer.

• 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: 13187140
• MDR Text Key: 289985893
• Report Number: 8010047-2022-01032
• Device Sequence Number: 1
• Product Code: FBK
• UDI-Device Identifier: 04953170260018
• UDI-Public: 04953170260018
• 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: 04/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NM-401L-0423
• Device Lot Number: 14V 05
• 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: 03/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1