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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 Problems Break (1069); No Apparent Adverse Event (3189)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/16/2019
Event Type  malfunction  
Manufacturer Narrative
Please note, we were not aware that the device for this complaint was actually related to this current complaint until 07-may-2020 as when we originally received it in february 2020 it was incorrectly related to (b)(4) (ref emdr # 3001845648-2020-00047). This error was realised on 07-may-2020 and for this reason we only became aware of this complaint on 07-may-2020. 510 k # - k092359. Investigation is still pending. A follow up mdr will be submitted to include the investigation conclusions.
 
Event Description
Device with rpn echo-hd-19-a was returned on 19th february 2020, lab evaluation confirmed device to be broken in 4 places, 3 proximal breakages and 1 distal breakage. Initially this device was believed to be related to complaint (b)(4) (ref emdr # 3001845648-2020-00047), however this is now known to be wrong as actual complaint device for (b)(4) (ref emdr # 3001845648-2020-00047) was received on 07-may-2020. Please note, we were not aware that the device for this complaint was actually related to this current complaint until 07 -may-2020 as when we originally received it in february 2020 it was incorrectly related to (b)(4) (ref emdr # 3001845648-2020-00047). This error was realised on 07-may-2020 and for this reason we only became aware of this complaint on 07-may-2020. Additional information for this current complaint was received from the rep on the following dates: as per information received on 14-may-2020: in fact, the doctor had the same problem on the same day. He damaged both needles in the same way. It was a problem with the endoscope¿s erector. It wasn¿t the needles that were the problem, it was the faulty endoscope. (please note, other needle being referred to is that in (b)(4) ref emdr # 3001845648-2020-00047). As per information received on 26-may-2020: he needle broke outside the patient and no debris remained in the working channel.
 
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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 Key10122551
MDR Text Key199652765
Report Number3001845648-2020-00341
Device Sequence Number1
Product Code FCG
Combination Product (y/n)N
Reporter Country CodeFR
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 06/17/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/05/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberECHO-HD-19-A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/06/2020
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 Received05/12/2020
Was Device Evaluated by Manufacturer? Yes
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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