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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK IRELAND LTD ECHOTIP PROCORE ENDOBRONCHIAL HD BIOPSY NEEDLE FCG KIT, NEEDLE, BIOPSY

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COOK IRELAND LTD ECHOTIP PROCORE ENDOBRONCHIAL HD BIOPSY NEEDLE FCG KIT, NEEDLE, BIOPSY Back to Search Results
Model Number G34279
Device Problem Difficult to Advance (2920)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/03/2019
Event Type  malfunction  
Manufacturer Narrative
Pma/510(k) # k160229. One unit of echo-hd-22-ebus-p-c of lot c1587797 was returned opened in its original packaging. A proximal kink was observed on the needle. Needle was able to advance and retract with slight difficulty. Stylet able to be removed and inserted without issue. Prior to distribution, all echo-hd-22-ebus-p-c devices are subjected to functional checks and visual inspection to ensure device integrity. These inspections and functional checks are outlined in internal procedures in place at cook (b)(4), a review of the manufacturing records for echo-hd-22-ebus-p-c of lot number c1587797 did not reveal any discrepancies that could have contributed to this complaint issue. The review of relevant manufacturing records, confirms the failure mode has not previously occurred with the current lot number. Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with lot number c1587797. The notes section of the instructions for use, ifu0109-5 which accompanies this device instructs the user to; "visually inspect with particular attention to kinks, bends and breaks. If an abnormality is detected that would prohibit proper working condition, do not use" and ¿this device is intended for use with an olympus ebus scope" and "ensure the stylet is fully inserted when advancing the needle into the biopsy site". There is evidence to suggest that the customer did not follow the instructions for use in relation to type of scope used and the use of the stylet (ifu0109-5). A definitive root cause for the customer complaint could not be determined as circumstances of use cannot be replicated in the laboratory. A possible root cause could be attributed to user error as the stylet should not be partially removed prior to advancement of the needle into intended targeted site. Complaint is confirmed as the failure was verified in the laboratory. According to the initial reporter, the patient did not experience any adverse effects due to this occurrence. Complaints of this nature will continue to be monitored for potential emerging trends.
 
Event Description
Needle is not smooth during procedure(difficult to push needle out from shealth), but tested outside scope was fine (when it is in straight position). Very hard for doctor to use the needle to do biopsy process while dr (b)(6) try another set of needle is fine. Additional information provided on 25-jul-19 confirmed that the stylet was removed about 2-3cm when advancing to target site.
 
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Brand NameECHOTIP PROCORE ENDOBRONCHIAL HD BIOPSY 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 Key8921159
MDR Text Key219771245
Report Number3001845648-2019-00430
Device Sequence Number1
Product Code FCG
UDI-Device Identifier00827002342798
UDI-Public(01)00827002342798(17)220221(10)C1587797
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 07/25/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/22/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/21/2022
Device Model NumberG34279
Device Catalogue NumberECHO-HD-22-EBUS-P-C
Device Lot NumberC1587797
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/09/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date07/03/2019
Event Location Hospital
Date Manufacturer Received07/04/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/21/2019
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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