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U.S. Department of Health and Human Services

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

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COOK IRELAND LTD ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE FCG KIT, NEEDLE, BIOPSY Back to Search Results
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  
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.
 
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.
 
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Brand NameECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE
Type of DeviceFCG KIT, NEEDLE, BIOPSY
Manufacturer (Section D)
COOK IRELAND LTD
o halloran road
limerick
MDR Report Key7166971
MDR Text Key283482148
Report Number3001845648-2018-00004
Device Sequence Number1
Product Code FCG
Combination Product (y/n)N
Number of Events Reported1
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
0 Patients were Involved in the Event:
Date FDA Received01/05/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberG34785
Device Catalogue NumberECHO-HD-3-20-C
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date01/04/2018
Event Location Hospital
Date Manufacturer Received02/28/2018
Is This a Reprocessed and Reused Single-Use Device? No

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