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

Lot Number 8XV

Device Problems Difficult to Advance (2920); Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/11/2019

Event Type  malfunction  

Event Description

The fna needle formed a bend in it on the top where the sheath begins and it was difficult to pass the stylet through.It was used on a patient, but did not cause harm.

• Brand Name: OLYMPUS
• Type of Device: BIOPSY NEEDLE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2400 ringwood ave.; san jose CA 95131
• MDR Report Key: 8535268
• MDR Text Key: 142625843
• Report Number: 8535268
• 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: 04/09/2019

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: No Information
• Device Lot Number: 8XV
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/09/2019
• Date Report to Manufacturer: 04/22/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/22/2019
• Type of Device Usage: N
• Patient Sequence Number: 1