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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
Catalog Number ECHO-1-22
Device Problem Off-Label Use (1494)
Patient Problems Hematoma (1884); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/21/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Investigation is still pending. A follow up mdr will be submitted to include the investigation conclusions.
 
Event Description
Rosa et al 2021- eus-guided fine needle tattooing (eus-fnt) for preoperative localization of small pancreatic neuroendocrine tumors (p-nets) the aim of this paper is to evaluate the safety and efficacy of preoperative endoscopic ultrasound guided fine needle tattooing (eus-fnt) to facilitate intraoperativedetection of pnets. Retrospective revision of prospectively maintained database of consecutive patients with pnets who, between january 2015 to april 2019, have undergone eus-fnt and subsequent surgical resection at the fondazione policlinico a. Gemelli irccs, rome, italy. Eus-fnt was done using a 22-gauge fna needle (echotip ultra, cook endoscopy, winston-salem, n. C. ) previously filled with a solution of highly purified carbon particles (spot®, gi supply, comp hill, pa, us). The needle was advanced directly into the center of the lesion or immediately adjacent to the lesion towards the pancreatic head and tattooing was then performed by gentle intralesional or intrapancreatic injection of 1¿2 ml of the spot® solution, until a hyperechoic spot appeared in the eus field of view in the proximity of the needle tip. The volume of spot® ink that was injected varied between 1¿2 ml, depending on the size of the lesion and the corresponding pancreatic segment. After injection, the needle was left in place for 30 s and then withdrawn, to decrease the risk of ink spilling outside of the tumor. The procedure was carried out using the conventional curvilinear eus. Tattooing was performed by intralesional injection of 1¿2 ml of spot® ink (spot®, gi supply, comp hill, pa, us) using a standard 22 gauge eus fna needle. A total of 16 patients underwent eus-fnt during the study period. There were 5 males and 11 females,with a mean age of 53 years (range 21¿73). Twelve were functional insulinomas, while the other 4 were nfpnets, with a ki-67 between 4 and 5%. Fifteen days from the eus-fnt procedure, a small hematoma and retraction of the pancreatic capsule were intraoperatively detected. The hematoma, however, did not interfere with the planned surgical resection. This complaint opened to capture the off-label use of the echo-1-22 device.
 
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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
sinead o'leary
o halloran road
national technology park
limerick 
MDR Report Key11743593
MDR Text Key280547082
Report Number3001845648-2021-00354
Device Sequence Number1
Product Code FCG
Combination Product (y/n)N
PMA/PMN Number
K083330
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Literature
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 08/05/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/29/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberECHO-1-22
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date09/21/2020
Event Location Hospital
Date Manufacturer Received03/31/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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