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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK IRELAND LTD UNKNOWN FCG KIT, NEEDLE, BIOPSY

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COOK IRELAND LTD UNKNOWN FCG KIT, NEEDLE, BIOPSY Back to Search Results
Catalog Number UNKNOWN
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Pancreatitis (4481)
Event Date 10/08/2012
Event Type  Injury  
Event Description
Madhoun 2012 "the diagnostic accuracy of 22 gauge and 25 gauge needles in endoscopic ultrasound-guided fine needle aspiration of solid pancreatic lesions: a meta-analysis. This meta-analysis suggests 25 g needle systems are more sensitive than 22 g needles for diagnosing pancreatic malignancy. The literature search yielded 36 potentially pertinent manuscripts for inclusion. Sixteen of these manuscripts were excluded immediately after initial review, most commonly because they did not pertain to the evaluation of pancreatic masses. Of the remaining twenty manuscripts, ten met the inclusion criteria for this meta-analysis (o fig. 1) [12-21). Two studies were subsequently excluded. One of these described the overall diagnostic accuracy, but reported insufficient data to allow calculation of specific operating characteristics (true positives, true negatives, false negatives and false positives) [19). The other study reported results for overall diagnostic accuracy among two groups (pancreatic and others vs. Submucosal lesions), so it was not possible to extract the data for pancreatic lesions alone [21 ]. Therefore eight studies were included in the final analysis. Eight studies involving 1292 subjects met the defined inclusion criteria. Of the 1292 patients, 799 were in the 22g group and 565 were in the 25g group (both needles were used in 72 patients). Eight studies were included in the sensitivity analysis and seven studies were included in the specificity analysis as one study comprised only patients with pancreatic cancer [14). The between-study variability (i. E. Heterogeneity) beyond what could be expected by sampling error was low with an 1 2 of 0. 0% for the pooled sensitivity of the 22 g needle and for the specificity of both needles. The 12 for the pooled sensitivity of the 25 g needle was 30%, which was not considered substantial heterogeneity as per the a priori definition. This systematic review and meta-analysis of eus-fna for solid pancreatic lesions included a large cohort of patients (n
=
1292) and quantitatively summarizes the available evidence regarding the diagnostic performance of the two most commonly used needle gauges for eus-fna of solid pancreatic lesions. These results demonstrated that the 25 g needle has superior sensitivity to the 22 g needle in this clinical context. All studies used disposable 25 g and 22 g eus-fna needles which incidentally all came from the same manufacturer (echotip and echotip ultra, cook endoscopy, (b)(4)). Of the five studies that reported adverse events, three described no complications with either needle (12, 13,20], while one study reported a 2% (11/540) risk of pancreatitis using the 22g needle (15], and another reported two cases of pancreatitis (2%) but did not specify the needle type (18]. ¿another study reported 2 cases of pancreatitis (2%) but did not specify the needle type. ¿.
 
Manufacturer Narrative
Possible 510 k #'s: k083330, k092359 and k142688. Investigation is still pending. A follow up mdr will be submitted to include the investigation conclusions.
 
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Brand NameUNKNOWN
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
aisling hassett
o halloran road
national technology park
limerick 
MDR Report Key13050821
MDR Text Key288289878
Report Number3001845648-2021-00885
Device Sequence Number1
Product Code FCG
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Literature
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/05/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/21/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date10/08/2012
Event Location Hospital
Date Manufacturer Received11/25/2021
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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