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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 Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
510 (k) number: k083330. (b)(4). Investigation is still pending. A follow up mdr will be submitted to include the investigation conclusions.
 
Event Description
"during an intervention requiring tissue samples, the needle deconsolidated from the rest of the device. The needle deconsolidated after being removed from the patient. Another needle had to be de-sterilized to continue the procedure. The operator, trained for several years and used to working with this device, had not encountered this kind of problem before. ".
 
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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 
061334440
MDR Report Key8004815
MDR Text Key126391523
Report Number3001845648-2018-00499
Device Sequence Number1
Product Code FCG
UDI-Device Identifier00827002315204
UDI-Public(01)00827002315204(17)201122(10)C1424356
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
Report Date 10/25/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/25/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/22/2020
Device Model NumberG31520
Device Catalogue NumberECHO-19
Device Lot NumberC1424356
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/23/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date10/25/2018
Event Location Hospital
Date Manufacturer Received09/28/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/22/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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