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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK IRELAND LTD QUICK-CORE ULTRASOUND BIOPSY NEEDLE FCG KIT, NEEDLE, BIOPSY

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COOK IRELAND LTD QUICK-CORE ULTRASOUND BIOPSY NEEDLE FCG KIT, NEEDLE, BIOPSY Back to Search Results
Catalog Number EUSN-19-QC
Device Problem Material Deformation (2976)
Patient Problem Foreign Body In Patient (2687)
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
 
Event Description
Literature complaint: comparison of eus-guided tissue acquisition using two different 19-gauge core biopsy needles: a multicenter, prospective, randomized, and blinded study. Dewitt (2015). As reported to customer relations: "the needle fractured during pancreatic tissue sampling. The authors noted that several factors contributed to this event (i. E. , long endoscope position, difficult depression of the plunger, slight elevator use, and acute needle angle into the target). The patient underwent pancreatoduodenectomy 6 weeks later for treatment of the underlying disease and foreign body removal. ".
 
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Brand NameQUICK-CORE ULTRASOUND 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 Key7852156
MDR Text Key119489813
Report Number3001845648-2018-00418
Device Sequence Number1
Product Code FCG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K013356
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/06/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/06/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberEUSN-19-QC
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date08/14/2018
Event Location Hospital
Date Manufacturer Received08/17/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 09/06/2018 Patient Sequence Number: 1
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