MAUDE Adverse Event Report: COOK, INC. ECHOTIP PROCORE; BIOPSY NEEDLE

Model Number G34279

Device Problems Device Inoperable (1663); Mechanical Jam (2983)

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

Event Date 10/12/2016

Event Type  malfunction  

Event Description

During an endobronchial ultrasound, the echotip procore device did not work.The needle jammed in the sheath.A new device was opened, which worked.The procedure continued and was completed successfully.

• Brand Name: ECHOTIP PROCORE
• Type of Device: BIOPSY NEEDLE
• Manufacturer (Section D): COOK, INC.; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6228862
• MDR Text Key: 64057649
• Report Number: 6228862
• Device Sequence Number: 1
• Product Code: FCG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 02/08/2019
• Device Model Number: G34279
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/28/2016
• Device Age: 8 MO
• Event Location: Hospital
• Date Report to Manufacturer: 11/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Weight: 74