MAUDE Adverse Event Report: COOK IRELAND LTD ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE; FCG KIT, NEEDLE, BIOPSY

Model Number G34785

Device Problems Material Perforation (2205); Device Issue (2379); Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

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

Event Date 12/06/2017

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) # k142688.(b)(4).Investigation is pending.A follow up mdr will be submitted to include the investigation conclusions.

Event Description

While using the needle, the needle lock did not fit properly in its place.

Event Description

While using the needle, the needle lock did not fit properly in its place.

Manufacturer Narrative

Pma/510(k) # k142688 (b)(4).Exemption number: e2016031 (b)(4) investigation is pending.A follow up mdr will be submitted to include the investigation conclusions.

Event Description

While using the needle, the needle lock did not fit properly in its place.

Manufacturer Narrative

Pma/510(k) # k142688.(b)(4).Exemption number: e2016031.(b)(4).Investigation is pending.A follow up mdr will be submitted to include the investigation conclusions.

Event Description

This follow up report is being submitted to cancel the initial report.Device was evaluated the 07-mar-18 confirming: no needle exposure, no retraction/ advancement issues, no issue noted with either lock/ sheath adjuster, no issues with the needle tip, stylet can be inserted/ reinserted with ease, slight crack at sheath thumbscrew- sheath adjuster slipping.The event does not meet the criteria of an fda ¿serious injury¿ report or ¿malfunction¿ report as per fda guidelines ¿medical device reporting for manufacturers (2016)¿.Report was submitted based on conservative assumption the needle lock was the issue not the sheath lock as later confirmed.

Manufacturer Narrative

Pma/510(k) # k142688.(b)(4).Exemption number: e2016031.(b)(4).This follow up report is being submitted to cancel the initial mdr report.A conservative approach was taken in initially assessing this complaint.After device evaluation 07-mar-18 confirming: no needle exposure, no retraction/ advancement issues, no issue noted with either lock/ sheath adjuster, no issues with the needle tip, stylet can be inserted/ reinserted with ease, slight crack at sheath thumbscrew- sheath adjuster slipping.This event does not meet the fda mdr reporting criteria.

• Brand Name: ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE
• Type of Device: FCG KIT, NEEDLE, BIOPSY
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 7166971
• MDR Text Key: 97588670
• Report Number: 3001845648-2018-00004
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 00827002347854
• UDI-Public: (01)00827002347854(17)200613(10)C1367041
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/28/2018

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: Health Professional
• Device Model Number: G34785
• Device Catalogue Number: ECHO-HD-3-20-C
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/04/2018
• Event Location: Hospital
• Initial Date Manufacturer Received: 12/07/2017
• Initial Date FDA Received: 01/05/2018
• Supplement Dates Manufacturer Received: 12/07/2017; 12/07/2017; 02/28/2018
• Supplement Dates FDA Received: 01/31/2018; 02/28/2018; 03/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1