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U.S. Department of Health and Human Services

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

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COOK IRELAND LTD ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE FCG KIT, NEEDLE, BIOPSY Back to Search Results
Model Number G34785
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/12/2018
Event Type  malfunction  
Manufacturer Narrative
The 510(k) number: k142688. (b)(4). Device evaluation the echo-hd-3-20-c device of unknown lot number involved in this complaint was returned for evaluation without original packaging. With the information provided, document based investigation was conducted. The device related to this occurrence underwent a laboratory evaluation on the 29 august 2018. Needle break at proximal end. Syringe was missing. No advancement or retraction due to needle breakage. Visual and functional checks were completed. Measured length of proximal section of needle 33. 5 cm from bottom of hub. Measured rest of the needle 136. 7 cm. The customer complaint is considered to be confirmed as the failure was verified in the laboratory. Root cause: a definitive root cause for the customer complaint could not be determined as the exact operational conditions of use could not be replicated in the laboratory setting and with limited information received. However it is possible that device handling or excessive force was applied causing the needle breakage when attaching or detaching the device to the scope. A capa has been initiated to document and track the actions taken to investigate and to address needle breaking, kinking or crumpling within the handle assembly and kinking or breaking of the sheath at the sheath/sheath extender junction. Document review: as the echo-hd-3-20-c device is of unknown lot number, a review of the relevant manufacturing records cannot be conducted. Prior to distribution, all echo-hd-3-20-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 (b)(4). Ifu review: the notes section of the instructions for use, which accompanies this device instructs the user to inspect the device prior to use for any damage: "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. Summary: the customer complaint is considered to be confirmed as the failure was verified in the laboratory. The risk was determined to be no risk (category iii). 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
Customer used a biopsy needle under echo endoscopy and the needle broke at the second passage. They had to use a second needle to achieve the procedure with success. "as per complaint form!; the needle broke at the second passage. They had to use a second needle to achieve the procedure with success.
 
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Brand NameECHOTIP PROCORE HIGH DEFINITION ULTRASOUND 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 Key7864737
MDR Text Key120540734
Report Number3001845648-2018-00421
Device Sequence Number1
Product Code FCG
UDI-Device Identifier00827002347854
UDI-Public(01)00827002347854(17)210314(10)C1464284
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
Type of Report Initial
Report Date 09/11/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/11/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/14/2021
Device Model NumberG34785
Device Catalogue NumberECHO-HD-3-20-C
Device Lot NumberC1464284
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/28/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date09/11/2018
Event Location Hospital
Date Manufacturer Received08/15/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/14/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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