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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 Failure to Advance (2524)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/25/2019
Event Type  malfunction  
Manufacturer Narrative
Pma/510(k) # k080330. 1 unit of lot number c1534336 of echo-19 was returned opened in its original packaging. The device related to this occurrence underwent a laboratory evaluation. The tip of the needle was found to be deformed/bent. Prior to distribution, all echo-19 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-19 of lot number c1534336 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 c1534336. 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". There is no evidence to suggest that the customer did not follow the instructions for use. The failure of needle tip bent was observed in the laboratory. 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 advancement into a hard lesion or presence of biological matter could contribute to the advancement difficulty. 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 cannot be advanced in endoscopy. User tried several times but failed. User changed another same device to complete the biopsy. Device evaluated and a distal kink on the needle was observed.
 
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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 Key8944399
MDR Text Key217464183
Report Number3001845648-2019-00442
Device Sequence Number1
Product Code FCG
UDI-Device Identifier00827002315204
UDI-Public(01)00827002315204(17)210828(10)C1534336
Combination Product (y/n)N
Reporter Country CodeCN
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
Report Date 05/31/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/29/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/28/2021
Device Model NumberG31520
Device Catalogue NumberECHO-19
Device Lot NumberC1534336
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/28/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date04/29/2019
Event Location Hospital
Date Manufacturer Received04/29/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/28/2018
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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