• Decrease font size
  • Return font size to normal
  • Increase font size
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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

COOK IRELAND LTD ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE FCG KIT, NEEDLE, BIOPSY Back to Search Results
Model Number G53585
Device Problem Material Deformation (2976)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/09/2018
Event Type  Injury  
Manufacturer Narrative
510 (k) number: k142688. (b)(4). Investigation is still pending. A follow up mdr will be submitted to include the investigation conclusions.
 
Event Description
As reported to customer relations (cr), "the doctor reports difficulty in maneuvering the handle and when puncturing and retracting the needle it got stuck, in both needles the same happens. No patient complication. The doctor decided to use another needle of the boston brand. Both needles were used only and they did not achieve tissue since they were tubed. The needle is revised and we observe that the needle of both devices has a burr.
 
Event Description
As reported to customer relations (cr), the doctor reported difficulty in manouvering the handle and when puncturing and retracting the needle it gets stuck, in both needles the same happens. No patient complication. The doctor decided to use another needle of the boston brand. Both needles were used only and they did not achieve tissue since they were tubbed. The needle is revised and we observe that the needle of both devices has a burr.
 
Manufacturer Narrative
510 (k) number; k142688 cook (b)(4) ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer). Exemption number: e2016031 information pertaining to section g. 1 as follows: importer site contact and address: (b)(6) cook medical incorporated (cmi) 1025 acuff road p. O box 4195 bloomington indiana 47402-4195 importer site establishment registration number: 3005580113 investigation is still pending. A follow up mdr will be submitted to include the investigation conclusions.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key8019855
MDR Text Key126661575
Report Number3001845648-2018-00504
Device Sequence Number1
Product Code FCG
UDI-Device Identifier00827002535855
UDI-Public(01)00827002535855(17)201130(10)C1427326
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
Report Date 11/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/30/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/30/2020
Device Model NumberG53585
Device Catalogue NumberECHO-HD-19-C
Device Lot NumberC1427326
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/06/2018
Was the Report Sent to FDA? No
Distributor Facility Aware Date10/30/2018
Event Location Hospital
Date Manufacturer Received10/03/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 10/30/2018 Patient Sequence Number: 1
-
-