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

Model Number NA-201SX-4021

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/13/2018

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to olympus for evaluation.The cause of the reported complaint cannot be confirmed.As a preventive measure, the instruction manual for the device has directions for pre-procedure visual and functional inspection, including verification that the needle distal tip extends and retracts into the sheath.The instruction manual also has warnings and cautions for preventing breakage at the proximal end: ¿do not apply bending force to the handle section.¿ ¿if you feel excessive resistance while operating the needle, do not push the needle slider forcibly.¿ and ¿if you feel excessive resistance while operating the needle adjuster lever, release the needle adjuster lever once and fix it again.Otherwise, it could damage the needle adjuster lever¿.The instruction manual also advises, ¿always have a spare instrument available in case the primary instrument malfunctions.¿.

Event Description

Olympus was informed that in the middle of a diagnostic ebus procedure, the needle handle broke on the inside.A cracking noise was heard in the device handle when the needle was locked.The needle had just taken an additional sample and was stuck extended from the sheath.The clinician could no longer retract or reposition the needle despite pushing and pulling on the handle.The bronchoscope with the needle device inside and the needle tip sticking out of the needle sheath was withdrawn out of the patient.The physician went back in with a bronchoscope to examine the tissue and verified that there was no injury.The intended procedure was completed.

Manufacturer Narrative

This supplemental report is being submitted to provide the device evaluation results, update the lot number.The device was returned to olympus for evaluation.The evaluation confirmed the customer complaint for the needle broken within the device and the needle stuck in position.The evaluation found a sharp kink in the sheath of the insertion portion below the metal protector boot.This sharp kink had caused the inner metal tube to break, resulting in the needle not being able to retract.The probable cause for the damage is external applied stress and force.

• Brand Name: SINGLE USE ASPIRATION NEEDLE
• Type of Device: SINGLE USE ASPIRATION NEEDLE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to
• MDR Report Key: 7308569
• MDR Text Key: 101599234
• Report Number: 2951238-2018-00142
• Device Sequence Number: 1
• Product Code: FCG
• Combination Product (y/n): N
• PMA/PMN Number: PK050503
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NA-201SX-4021
• Device Catalogue Number: NA-201SX-4021
• Device Lot Number: 78V 03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN MODEL BRONCHOSCOPE, SERIAL NUMBER (B)(4)
• Patient Age: 66 YR