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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
Catalog Number ECHO-19
Device Problems Retraction Problem (1536); Device Damaged Prior to Use (2284)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
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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
sinead o'leary
o halloran road
national technology park
limerick 
MDR Report Key14775118
Report Number3001845648-2022-00375
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 Health Professional,User Facility,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 08/04/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/22/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberECHO-19
Device Lot NumberC1843681
Was Device Available for Evaluation? Device Returned to Manufacturer
Was the Report Sent to FDA? No
Distributor Facility Aware Date05/25/2022
Event Location Hospital
Date Manufacturer Received05/26/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/25/2021
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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