MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE INJECTOR; INJECTOR AND SHEATHSET

Model Number NM-401L-0423

Device Problems Break (1069); Retraction Problem (1536)

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

Event Date 06/15/2022

Event Type  malfunction  

Manufacturer Narrative

The subject device was sent to olympus for evaluation.Inspection and testing confirmed the reported event.Upon evaluation of the returned device, damage to the knife wire was found.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.However, if additional information becomes available this report will be supplemented accordingly.

Event Description

A user facility reported to olympus, the single use injector was unable to inject when needle was out.The event occurred during an unknown procedure.It was reported that the injector was tested in and out of the patient but showed the same results.According to the report, injection was possible when the needle was retracted, and a 2nd needle was used with the same result.There was no report of patient harm or user injury associated with this event.This complaint is related to patient identifier (b)(6) for the first device.

Manufacturer Narrative

A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, it¿s likely that the reported event was due to compressive buckling when the needle was extended due to increased friction resistance between the outer tube and needle tube.Possible causes for the friction resistance between the tubes include: the tube was coiled during the inspection for operation, the slider was pushed abruptly, the tube was buckled.Additionally, it¿s probable the tube buckling occurred when the device was inserted into the endoscope, removed from the sterile package or during pre-inspection.The root cause of this event was unable to be identified.The event can be prevented by following the instructions for use which state: ¿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): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer Contact: masaharu hirose ; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0-357 ; JA 036-0357 ; 426422891
• MDR Report Key: 15029892
• MDR Text Key: 301243049
• Report Number: 9614641-2022-00003
• Device Sequence Number: 1
• Product Code: FBK
• UDI-Device Identifier: 04953170422621
• UDI-Public: 04953170422621
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K902736
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2022
• 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: 19K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2021
• 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