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

Model Number NM-401L-0423

Device Problems Mechanical Problem (1384); Failure to Infuse (2340); Dent in Material (2526)

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

Event Date 11/14/2022

Event Type  malfunction  

Manufacturer Narrative

Initial reporter full address name of the facility : (b)(6).Investigation result: customer returned the device model nm-401l-0423, lot no k23 (supplementary information number of ¿07 ).Inspection and evaluation of the returned device noted fluid can be injected when the needle is in the extend position, fluid can be injected when the needle is in retract position.No buckling of the needle tube was observed, however, tube kinked was noted.The dhrs (device history records) have been reviewed.No abnormalities were detected in the device history record with the lot number for the following inspection items, which related to the reported phenomenon.The record review includes the following.Process inspection sheet.Quality inspection sheet.Nonconforming product report.The instruction manual contains the following descriptions, and it warns against this event.(b)(4) rev.11).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.The exact cause could not be conclusively identified by the following reason: the user's complaint was not confirmed with the returned device.Regarding the kinked tube, 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 kink.No abnormalities on the device was considered as no abnormalities were found in the device history record.Although the root cause of this event could not be determined, we will continue to monitor trends and take appropriate actions as necessary.Olympus will continue to monitor complaints for this device.

Event Description

It was reported at preparation for use (before procedure) for a therapeutic gastric ulcer case, the nurse inspected, test the injector (nm-401 l-0423), and found no problem.However, during the procedure, when the injector (with needle out) was inside the scope, the nurse injects the adrenaline solution and the solution were stuck and cannot flow through the lumen despite trying for many times.The nurse tried to examine and test the injector after taking it out from the scope, however, the same issue transpired.A second injector (same model, nm-401 l-0423) was opened, used to continue the procedure.The intended procedure was completed and the patient was reported to be in good status.There was no patient harm, no user injury reported due to the event.

• 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 (Section G): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16061897
• MDR Text Key: 308492516
• Report Number: 9614641-2022-00860
• Device Sequence Number: 1
• Product Code: FBK
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: K902736
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2022
• 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: 23K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/06/2022
• 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
• Treatment: SCOPEADRENALINE SOLUTION