MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE ASPIRATION NEEDLE; GENERAL-PURPOSE ENDOSCOPIC NEEDLE, SINGLE-USE

Model Number NA-401D-1521

Device Problem Material Puncture/Hole (1504)

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

Event Date 05/19/2022

Event Type  malfunction  

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.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, the reported event is known to be reproduced by the following mechanisms: (1) the tip of the sheath is pressed against the tissues of the trachea, bronchi, esophagus and surrounding organs, (2) the sheath bends when the scope is pushed while the sheath is pressed against the tissue, (3) if you try to push out the needle with the sheath bent, the tip of the needle will catch on the bent portion of the sheath, making it impossible to push out, (4) when the needle cannot be pushed out, if you try to force it out a defect may occur.Therefore, the relationship between the delayed procedure and device cannot be denied.The event can be detected/prevented by following the instructions for use (ifu) which state: ¿do not round the insertion tube smaller than 15 cm in diameter.The insertion tube may be damaged.¿ ¿do not insert the needle forcibly, insert the needle while it is not fully retracted into the tube, or insert it rapidly.It may suddenly protrude from the tip of the endoscope, resulting in perforation, pneumothorax, major bleeding, mucous membrane damage, or damage to the endoscope or this product.Also, if the resistance is high and insertion is difficult, return the angle of the endoscope until it can be inserted without difficulty.¿ ¿do not press the tip of the insertion tube against the tissue in the body cavity with excessive force.Doing so may lead to perforation, pneumothorax, major bleeding, mucous membrane damage, etc., or damage to the product.¿ ¿if you try to push the needle out of the tube with the tip of the insertion tube pressed against the tissue inside the body cavity or with the tip of the insertion tube buckled, resistance may increase.If there is a lot of resistance when pushing the needle out of the tube, do not force the needle out.If the tip of the tube is deformed and the needle is pushed out in this state, the needle may pierce the tube, leading to perforation, pneumothorax, major bleeding, damage to the mucous membrane, etc., and damage to the endoscope.¿ olympus will continue to monitor field performance for this device.

Manufacturer Narrative

This report is being updated to report additional information provided by the customer.New information is reported.

Event Description

The procedure being performed we as a bronchoscopy.There was a 5 minute delay in the procedure due to the device issue.The procedure was completed with washings instead to confirm cancer diagnosis.The customer hopes this is as relevant as an aspiration.The patient's current condition is reported as "unsure".

Event Description

The customer reports during an aspiration procedure using a single use aspiration needle, the needle punctured through the sheath/catheter.The procedure was delayed and the aspiration was not completed.There is no reported adverse effect to the patient as a result of this occurrence.The needle can not be returned to olympus for evaluation, it was discarded by the customer.

Manufacturer Narrative

The device referenced in this report was not returned to olympus for evaluation.The definitive cause of the user¿s experience cannot be determined at this time.The investigation is ongoing.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.

• Brand Name: SINGLE USE ASPIRATION NEEDLE
• Type of Device: GENERAL-PURPOSE ENDOSCOPIC NEEDLE, SINGLE-USE
• 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: 14772452
• MDR Text Key: 301404055
• Report Number: 8010047-2022-10525
• Device Sequence Number: 1
• Product Code: GAA
• UDI-Device Identifier: 04953170196683
• UDI-Public: 04953170196683
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: CLASS1-EXMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NA-401D-1521
• Device Lot Number: 16K
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/23/2022
• Initial Date FDA Received: 06/22/2022
• Supplement Dates Manufacturer Received: 06/21/2022; 09/05/2022
• Supplement Dates FDA Received: 07/18/2022; 09/21/2022
• 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