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

Model Number NA-201SX-4021

Device Problems Break (1069); Disconnection (1171)

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

Event Date 08/12/2019

Event Type  Injury  

Event Description

The user facility reported that during an endobronchial ultrasound bronchoscopy (ebus) procedure, the needle had broken off and could not located.There was no report of patient injury.A single-use aspiration needle was used during a bronchoscopy to obtain specimens from lymph nodes in the lungs.The device functioned normally for the first few passes.When doctor got to station 5r, and tried to pull the needle back into the sheath, the device wasn't responding, like it was disconnected from the handle.The needle was removed from the scope and the distal tip was noted to be missing.The doctor then used a different needle to finish his procedure.It was not clear if the needle broke inside or outside the body.It was not seen in the room or specimen containers.The doctor looked extensively for the needle in the lungs, but it was not seen.The patient had an uneventful recovery and was discharged to home in stable condition.Sus voluntary mw#5089212.

• 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 192-8 507; JA 192-8507
• MDR Report Key: 9080044
• MDR Text Key: 160553263
• Report Number: 2951238-2019-01122
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 04953170381911
• UDI-Public: 04953170381911
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 10/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/22/2022
• Device Model Number: NA-201SX-4021
• Device Lot Number: 93V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2019
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/17/2019
• Distributor Facility Aware Date: 08/19/2019
• Event Location: Hospital
• Date Report to Manufacturer: 10/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other