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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK IRELAND LTD ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE FCG KIT, NEEDLE, BIOPSY

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COOK IRELAND LTD ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE FCG KIT, NEEDLE, BIOPSY Back to Search Results
Model Number G31520
Device Problems Break (1069); Retraction Problem (1536); Activation, Positioning or Separation Problem (2906)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 10/03/2019
Event Type  malfunction  
Manufacturer Narrative
Investigation is still pending. A follow up mdr will be submitted to include the investigation conclusions.
 
Event Description
During the procedure the doctor noticed the 19g needle was rather stiff (didn`t move easily in and out of the sheet). While puncturing (2nd pass) something snapped and on the eus screen the noticed the needle seemed to have broken. They removed the needle and exchanged it for a 3-22. They finished the procedure without any problems.
 
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Brand NameECHOTIP ULTRA ENDOSCOPIC ULTRASOUND 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 
MDR Report Key9322055
MDR Text Key219791206
Report Number3001845648-2019-00594
Device Sequence Number1
Product Code FCG
UDI-Device Identifier00827002315204
UDI-Public(01)00827002315204(17)200324(10)C1339544
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
K083330
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
Report Date 12/12/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/14/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/24/2020
Device Model NumberG31520
Device Catalogue NumberECHO-19
Device Lot NumberC1339544
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/06/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date10/03/2019
Event Location Hospital
Date Manufacturer Received10/18/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/24/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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