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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK IRELAND LTD ECHOTIP PROCORE ENDOBRONCHIAL HD BIOPSY NEEDLE FCG KIT, NEEDLE, BIOPSY

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COOK IRELAND LTD ECHOTIP PROCORE ENDOBRONCHIAL HD BIOPSY NEEDLE FCG KIT, NEEDLE, BIOPSY Back to Search Results
Catalog Number ECHO-HD-25-EBUS-O-C
Device Problem Material Deformation (2976)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/21/2018
Event Type  Injury  
Manufacturer Narrative
510 (k) number; k160229. (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: "while completing an ebus procedure: using a 25g cook pro-tip fna needle. We were attempting to sample a lymphnode, the needle was unable to retract into the sheath, dr. Decided to take scope out of patient. Once scope removed noted that needle was bent at 90 degrees. Straightened needle with wire cutters to remove from scope. Needle checked afterwards it was intact. Patient was re-bronched to rule out injury. Small scratches noted. Patient alert, orientated, and vital signs stable. ".
 
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Brand NameECHOTIP PROCORE ENDOBRONCHIAL HD BIOPSY NEEDLE
Type of DeviceFCG KIT, NEEDLE, BIOPSY
Manufacturer (Section D)
COOK IRELAND LTD
o halloran road
limerick
Manufacturer (Section G)
COOK IRELAND LTD
o halloran road
national technology park
limerick
Manufacturer Contact
heather ryan
o halloran road
national technology park
limerick 
061334440
MDR Report Key8172802
MDR Text Key130616222
Report Number3001845648-2018-00598
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
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 02/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/18/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberECHO-HD-25-EBUS-O-C
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/19/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date12/18/2018
Event Location Hospital
Date Manufacturer Received11/26/2018
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/18/2018 Patient Sequence Number: 1
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