MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. OLYMPUS; BIOPSY NEEDLE

Model Number NA-201SX-4022

Device Problems Material Twisted/Bent (2981); Positioning Problem (3009)

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

Event Date 10/16/2019

Event Type  malfunction  

Event Description

Dr.Inserted the olympus ebus na-201sx-4022 needle into scope and stated that it didn't move right.He did obtain the first biopsy of node 7 with this needle.Needle was removed and an extreme bend to the needle was noted.He proceeded with a new olympus ebus needle (same product) and it worked without incident.The original needle was only used for the first biopsy pass of node 7.It was removed intact without any patient injury or known consequence.

• Brand Name: OLYMPUS
• Type of Device: BIOPSY NEEDLE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2400 ringwood ave; san diego CA 95131
• MDR Report Key: 9495589
• MDR Text Key: 172023835
• Report Number: 9495589
• Device Sequence Number: 1
• Product Code: FCG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/25/2019,10/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NA-201SX-4022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/25/2019
• Date Report to Manufacturer: 12/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 24090 DA