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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); Fracture (1260); No Apparent Adverse Event (3189)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/16/2019
Event Type  malfunction  
Manufacturer Narrative
Investigation is still pending. A follow-up /final vigilance report will be submitted to include the investigation conclusions.
 
Event Description
During echo endoscopy with biopsy, when staff wanted to make a ponction, difficulty to get the needle out of the echoendo. Needle broke off into echoendoscope. When needle was retrieved staff noticed a lack of bevelled edge. Consequences: longer anesthesia. Use of new needle. Extra financial cost.
 
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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 Key9625563
MDR Text Key220822316
Report Number3001845648-2020-00047
Device Sequence Number1
Product Code FCG
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K083330
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,Followup,Followup
Report Date 02/18/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/24/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/21/2021
Device Model NumberG31520
Device Catalogue NumberECHO-19
Device Lot NumberC1571035
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/28/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date12/16/2019
Event Location Hospital
Date Manufacturer Received12/27/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/21/2018
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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