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

Model Number NM-401L-0523

Device Problem Failure to Fire (2610)

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

Event Date 08/31/2021

Event Type  malfunction  

Manufacturer Narrative

There are three associated devices for this event.They are as below: first device patient identifier: (b)(6).Second device patient identifier: (b)(6).Third device patient identifier: (b)(6).This medwatch is for the third device, patient identifier: (b)(4).The device is not returned, as such a definitive root cause of the reported complaint cannot be determined at this time.Supplemental report(s) will be filed as the information becomes available.

Event Description

As reported for this event by the customer, the oleate or serum would not come out through the needle lumen with the needle out.The liquid was coming out with the needle sheathed.This device is used to inject ethanolamine oleate by intra-mucosal bronchial puncture, with the intention of closing small bronchopleural fistulas.It was not possible to use the device.Two other devices from different boxes were tried and had the same issue.There is no reported harm to any patient.

Manufacturer Narrative

Additional information has been received from the customer.This supplemental report is being submitted to provide this information.The event occurred during a therapeutic procedure.There was an unspecified delay in the procedure.The procedure was completed with another similar device.There was no harm to the patient.The device is discarded.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information based on the legal manufacturer¿s investigation.As stated in the initial mdr, the subject device was not returned to olympus for evaluation, as it has been discarded by the user facility staff after use.Therefore, the reported phenomenon and condition of the device could not be confirmed.However, the legal manufacturer reviewed the device history record (dhr) and no abnormalities detected during the manufacturing of the device.There were no abnormalities detected in the dhr for the following items, which is related to the reported phenomenon: needle extension and retraction, extended length of needle, no bent/kink/crack/scratch on the tube, and injection of the liquid.The device instruction manual contains the following descriptions, and it warns against this reported event (gk6631 rev10): ¿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 olympus for 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: 12540493
• MDR Text Key: 273603451
• Report Number: 8010047-2021-12386
• Device Sequence Number: 1
• Product Code: FBK
• UDI-Device Identifier: 04953170422645
• UDI-Public: 04953170422645
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K902736
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/26/2022

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 Model Number: NM-401L-0523
• Device Lot Number: 97K
• Was Device Available for Evaluation?: Yes
• 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?: 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