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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
Model Number G34282
Device Problem Break (1069)
Patient Problem Foreign Body In Patient (2687)
Event Date 11/30/2018
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
Dr (b)(6) performed an ebus. At the end of the procedure it was noted that the tip of the needle had sheared off. The procedure was not a difficult one. A ct was performed and the tip was in the node. A bronchoscope was performed and the tip was retrieved.
 
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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 Key8184440
MDR Text Key131008961
Report Number3001845648-2018-00613
Device Sequence Number1
Product Code FCG
Combination Product (y/n)N
Reporter Country CodeAS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 01/17/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/20/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/17/2020
Device Model NumberG34282
Device Catalogue NumberECHO-HD-25-EBUS-O-C
Device Lot NumberC1327235
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/29/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date12/20/2018
Event Location Hospital
Date Manufacturer Received12/03/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/17/2017
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: 12/20/2018 Patient Sequence Number: 1
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