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U.S. Department of Health and Human Services

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

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COOK IRELAND LTD ECHOTIP ULTRA HIGH DEFINITION ULTRASOUND ACCESS NEEDLE FCG KIT, NEEDLE, BIOPSY Back to Search Results
Catalog Number ECHO-HD-19-A
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
Pma/510(k) #k092359. Investigation is still pending. A follow up mdr will be submitted to include the investigation conclusions.
 
Event Description
Paper title: drainage of the right liver under eus guidance: a bridge technique allowing drainage of the right liver through the left liver into the stomach or jejunum. Country of origin: (b)(6). Patient conditions: patients with inaccessible papilla due to altered anatomy or duodenal invasion and drainage under eus guidance and bridge technique without previous biliary drainage were included in the study. Brief description: both ultra 19-a and ultra 19 were off label use. (related to 285780). Event description: twelve patients were included in the study. Inclusion criteria were malignant hilar stenosis of the bile duct, inaccessible papilla due to duodenal stenosis or altered anatomy, and an attempt of the bridge technique. The procedure was performed with patients intubated and sedated and in the supine position. The liver segment ii or iii was punctured with a 19 g access needle ((echotip ultra 19- a, cook medical, usa) or a standard 19 g needle (echotip ultra 19, cook medical) with a therapeutic echoendoscope (eg38utk [pentax, (b)(4)]). Both ultra 19-a and ultra 19 were off label use.
 
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Brand NameECHOTIP ULTRA HIGH DEFINITION ULTRASOUND ACCESS 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 Key9443751
MDR Text Key220038337
Report Number3001845648-2019-00703
Device Sequence Number1
Product Code FCG
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K092359
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 01/31/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/10/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberECHO-HD-19-A
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 Date12/10/2019
Event Location Hospital
Date Manufacturer Received11/12/2019
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: 12/10/2019 Patient Sequence Number: 1
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