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U.S. Department of Health and Human Services

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

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COOK IRELAND LTD ECHOTIP ULTRA ENDOBRONCHIAL HD ULTRASOUND NEEDLE FCG KIT, NEEDLE, BIOPSY Back to Search Results
Model Number G52011
Device Problem Break (1069)
Patient Problem Foreign Body In Patient (2687)
Event Type  Injury  
Manufacturer Narrative
Pma/510(k) # k160229. Complaint device was not returned therefore a document based review will be performed. Prior to distribution, all echo-hd-22-ebus-o 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 cirl. A review of the manufacturing records for echo-hd-22-ebus-o of lot number c1631342 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 c1631342. The notes section of the instructions for use, 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 "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 the use of the stylet. A definitive root cause could not be determined from the available information. 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 based on the customer's testimony. According to the initial reporter, the patient did not experience any adverse effects due to this occurrence. The needle part was removed with a forceps. Complaints of this nature will continue to be monitored for potential emerging trends.
 
Event Description
Needle's fracturing during the procedure, if the needle needs to pass from hard cartilage to reach the tissue, needle shape can change. Especially, aspiration moment is most important to avoid the needle fracturing. Because nitinol stylet support the lumen for the first punching but aspiration moment, unfortunately lumen stays empty. In this case, you can fracture the needle easy. Every problem may be about using, but such a fracture problem, i cannot say anything to solve this problem. As per complaint form: " needle has been pull it out first. Fractured needle part has been taken with forceps. ".
 
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Brand NameECHOTIP ULTRA ENDOBRONCHIAL HD 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 
MDR Report Key9516356
MDR Text Key189009158
Report Number3001845648-2019-00769
Device Sequence Number1
Product Code FCG
Combination Product (y/n)N
Reporter Country CodeTU
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 11/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/24/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/15/2022
Device Model NumberG52011
Device Catalogue NumberECHO-HD-22-EBUS-O
Device Lot NumberC1631342
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location Hospital
Date Manufacturer Received11/27/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/15/2019
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: 12/24/2019 Patient Sequence Number: 1
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