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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK IRELAND LTD ECHOTIP ULTRA ENDOBRONCHIAL HD ULTRASOUND NEEDLE

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COOK IRELAND LTD ECHOTIP ULTRA ENDOBRONCHIAL HD ULTRASOUND NEEDLE Back to Search Results
Catalog Number ECHO-HD-22-EBUS-O
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Blood Loss (2597)
Event Date 07/25/2019
Event Type  Injury  
Manufacturer Narrative
Common device name: fcg kit, needle, biopsy. Procode: fcg.
 
Event Description
As reported to customer relations "they started using an olympus needle. After using that olympus needle, they decided to use a cook needle. Toward the end, once they were done with the procedure, the patient was having some bleeding while being suctioned and cleaned up. It could not be determined which needle caused the bleeding. ".
 
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Brand NameECHOTIP ULTRA ENDOBRONCHIAL HD ULTRASOUND NEEDLE
Manufacturer (Section D)
COOK IRELAND LTD
o halloran road
limerick
MDR Report Key8889106
MDR Text Key154173004
Report Number3005580113-2019-00243
Device Sequence Number1
Product Code FCG
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation
Type of Report Initial
Report Date 08/13/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/13/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberECHO-HD-22-EBUS-O
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/13/2019
Distributor Facility Aware Date07/26/2019
Event Location Hospital
Date Report to Manufacturer08/13/2019
Was Device Evaluated by Manufacturer? No Answer Provided
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: 08/13/2019 Patient Sequence Number: 1
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