MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE ASPIRATION NEEDLE NA-U401SX

Model Number NA-U401SX-4021

Device Problems Mechanical Problem (1384); Peeled/Delaminated (1454)

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

Event Date 02/27/2022

Event Type  malfunction  

Event Description

It was reported during an unspecified procedure, the user felt resistance when the needle of na-u401sx-4021 protruded, and when the needle tip came out, a foreign substance such as debris came out from the sheath.There was no patient harm or injury reported due to the event.No user injury reported.Device evaluation found the device tip (green insertion), the sheath was deformed, the green tube (coil sheath ) was peeled off and was missing.This report is being submitted for reportable malfunction of the needle (deformed sheath) , green tube peeled off and was missing observed during device evaluation.

Manufacturer Narrative

The subject device was received and evaluated.Device inspection and evaluation, the following findings were noted : the product was "na-u401sx-4021" and the lot number was "18k27".During inspection check, it was found the tip of the green insertion part, the sheath was deformed.Coli sheath peeled off.The green tube had peeled off and was missing.Functional test confirmed the insertion and removal of the needle tube able to insert and remove it without any problem.There was no deformation at the tip of the needle tube.There was no buckling on the coil sheath.The outer diameter of the coil sheath observed with no issue.There were no other abnormalities that could lead to the phenomenon reported.It was review of dhrs (device history records) for the lot number of the equipment showed no abnormalities in the inspection items ( below) related to the event/phenomenon indicated.· operation of needle slider · appearance of needle tube · coil sheath appearance ifu (instruction for use) (fig.No.Gk9897, no.1 ), the following warning was given to the description related to this event : · do not insert the suction biopsy needle with the endoscope at an angle.It may damage the endoscope or suction biopsy needle.· do not insert the suction biopsy needle into the endoscope vigorously.Sudden protrusion from the tip of the endoscope may lead to perforation, major bleeding, mucosal damage, etc., or damage to the endoscope or suction biopsy needle.If the resistance is high and it is difficult to insert, return the endoscope angle to the point where it can be inserted without difficulty.It is probable that on the event/phenomenon reported the coil sheath was removed when the angle of the endoscope was strict, causing contact with the internal parts of the endoscope and the green coil sheath peeled off.Supplemental report(s) will be submitted should any relevant new information is available.Investigation is ongoing.This report will be supplemented accordingly following investigation.

Manufacturer Narrative

This report is being supplemented based on customer response and updates regarding event reported.Communication with the customer stated that foreign object found and removed the device from the scope.Foreign object has not fallen into the patient body.No other information provided.Investigation is ongoing.This report will be supplemented accordingly following investigation.

Manufacturer Narrative

Correction to g3 of the initial medwatch (mfr# 8010047 2022 05726).The aware date should be 10-mar-2022.This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The investigation confirmed the reported problem with the sheath of the suction biopsy needle.When the sheath was projected with the angle of the scope (upmax), it contacted the internal parts (metal pipe) of the scope and the frictional resistance increased.The investigation did not find any problems with the insertion/removal of the needle tube.Additionally, no foreign material was found on the device.A root cause for the reported issue was not established.Olympus will continue to monitor field performance for this device.Investigation activities have been opened to manage the actions related to this issue and any required mdr reporting.

• Brand Name: SINGLE USE ASPIRATION NEEDLE NA-U401SX
• Type of Device: SINGLE USE ASPIRATION NEEDLE
• 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: 14017519
• MDR Text Key: 290078009
• Report Number: 8010047-2022-05726
• Device Sequence Number: 1
• Product Code: FCG
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K160098
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NA-U401SX-4021
• Device Lot Number: 18K27
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/26/2021
• 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