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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; FCG KIT, NEEDLE, BIOPSY
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COOK IRELAND LTD ECHOTIP ULTRA ENDOBRONCHIAL HD ULTRASOUND NEEDLE; FCG KIT, NEEDLE, BIOPSY Back to Search Results
Catalog Number ECHO-HD-22-EBUS-O
Device Problem Use of Device Problem (1670)
Patient Problem Blood Loss (2597)
Event Date 07/25/2019
Event Type  Injury  
Manufacturer Narrative
Pma/510(k) # k160229.Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.
 
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.".
 
Manufacturer Narrative
Pma/510(k) # k160229.Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.
 
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.".
 
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.".
 
Manufacturer Narrative
Complaint device was not returned therefore a document based review will be performed.Prior to distribution, all echo-hd-22-ebus-o devices are subjected to functional checks and visual inspection to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.As the lot number is unknown the device history records could not be reviewed as part of the investigation.The notes section of the instructions for use, which accompanies informs the user about the potential complications as follows; "perforation, hemorrhage, aspiration, fever, infection, allergic reaction to medication, hypotension, damage to blood vessels, nerve damage, pain, pneumoperitoneum, tumour seeding, respiratory depression or arrest, cardiac arrhytmia or arrest, and death".There is no evidence to suggest that the customer did not follow the instructions for use.A definitive root cause could not be determined from the available information.A possible root cause is difficult to determine but could be attributed to unintended puncture as bleeding that leads to suction and injection of epinephrine is not common.The issue could also possibly have occurred while using the olympus needle or could have been due to the suctioning procedure.The best assessment is that as there was an unintended puncture.Complaint is confirmed based on the customer's testimony.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.
 
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Brand Name
ECHOTIP ULTRA ENDOBRONCHIAL HD ULTRASOUND NEEDLE
Type of Device
FCG KIT, NEEDLE, BIOPSY
Manufacturer (Section D)
COOK IRELAND LTD
o halloran road
limerick
MDR Report Key8924366
MDR Text Key156287062
Report Number3001845648-2019-00432
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
Report Date 09/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberECHO-HD-22-EBUS-O
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date07/25/2019
Event Location Hospital
Initial Date Manufacturer Received 07/26/2019
Initial Date FDA Received08/23/2019
Supplement Dates Manufacturer Received07/26/2019
07/26/2019
Supplement Dates FDA Received09/19/2019
10/18/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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