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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK IRELAND LTD; FCG KIT, NEEDLE, BIOPSY
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COOK IRELAND LTD; FCG KIT, NEEDLE, BIOPSY Back to Search Results
Catalog Number UNKNOWN
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Inflammation (1932)
Event Date 06/28/2016
Event Type  Injury  
Manufacturer Narrative
Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.As exact rpn is unknown then this is the list of potential 510 k #¿s: k160229 or k083330 or k142688.Please note, due to limited information provided in this literature, we cannot confirm of the echo devices used, which of the following caused the pancreatitis , the following is a list of potential rpn¿s: fnb: echo-hd-22-ebus-o - c / echo-hd-25-ebus-o ¿ c (k160229) or echo-hd-22-c / echo-hd-25-c (k142688) or fna: echo-hd-22-ebus-o / echo-hd-25-ebus-o (k160229) or echo-1-22 / echo-25 (k083330).As per 'medical device reporting for manufacturer's (2016), section 4.16.2 'submit an individual report for each device identified if the generic names of the devices are different.' therefore, one report will be submitted in relation to the above serious injury.
 
Event Description
Title: diagnostic accuracy of 22/25-gauge core needle in endoscopic ultrasound-guided sampling: systematic review and meta-analysis - oh et al 2016.Aim: to compare the diagnostic accuracy of endoscopic ultrasound- guided core needle aspiration with that of standard fine-needle aspiration by systematic review and meta-analysis.This file is created to capture 1 cases of pancreatitis.Please note, due to limited information provided in this literature, we cannot confirm of the echo devices used, which of the following caused the pancreatitis , the following is a list of potential rpn¿s: fnb: echo-hd-22-ebus-o - c / echo-hd-25-ebus-o - c or echo-hd-22-c / echo-hd-25-c or fna: echo-hd-22-ebus-o / echo-hd-25-ebus-o or echo-1-22 / echo-25.As per 'medical device reporting for manufacturer's (2016), section 4.16.2 'submit an individual report for each device identified if the generic names of the devices are different.' therefore, one report will be submitted in relation to the above serious injury.
 
Manufacturer Narrative
As exact rpn is unknown then this is the list of potential 510 k #¿s: k160229 or k083330 or k142688.Please note, due to limited information provided in this literature, we cannot confirm of the echo devices used, which of the following caused the pancreatitis , the following is a list of potential rpn¿s: fnb: echo-hd-22-ebus-o - c / echo-hd-25-ebus-o ¿ c (k160229) or echo-hd-22-c / echo-hd-25-c (k142688) or fna: echo-hd-22-ebus-o / echo-hd-25-ebus-o (k160229) or echo-1-22 / echo-25 (k083330).As per 'medical device reporting for manufacturer's (2016), section 4.16.2 'submit an individual report for each device identified if the generic names of the devices are different.' therefore, one report will be submitted in relation to the above serious injury.Device evaluation: the unknown devices of unknown lot numbers involved in this complaint was not available for evaluation.With the information provided, a document based investigation was conducted.This file was created from the attached journal article.Reference "oh et al 2016" complaint files (b)(6) and (b)(6) were opened as a result of this paper.This file (b)(6) was opened to investigate one case of pancreatitis.Documents review including ifu review: as the rpn and lot number of the complaint stents are unknown, a review of the relevant manufacturing records cannot be conducted.However, prior to distribution echo devices are subjected to a visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.As the echo devices (22g or 25 g echotip or echotip procore) from unknown lot number, a review of the relevant manufacturing records cannot be conducted.As per the instructions for use, ifu0077-4 which informs the user about the potential complications "those associated with gastrointestinal endoscopy include, but are not limited to: perforation, hemorrhage, aspiration, fever, infection, allergic reaction to medication, hypotension, respiratory depression or arrest, cardiac arrhythmia or arrest, damage to blood vessels, nerve damage, and acute pancreatitis.Those associated with eus needle biopsy include but are not limited to: pain, death, peritonitis, portal vein gas and thrombosis, pneumoperitoneum and tumor seeding of the needle tract.Root cause review: a definitive root cause could not be determined from the available information.However there was no evidence of a failure reported associated with the actual devices.As per the ifu potential complications include acute pancreatitis.Summary: complaint is confirmed based on customer testimony.The patient outcome is unknown post pancreatitis as reported.Complaints of this nature will continue to be monitored for potential emerging trends.Attachment: [oh et al 2016.Pdf].
 
Event Description
Title: diagnostic accuracy of 22/25-gauge core needle in endoscopic ultrasound-guided sampling: systematic review and meta-analysis - oh et al 2016.Aim: to compare the diagnostic accuracy of endoscopic ultrasound- guided core needle aspiration with that of standard fine-needle aspiration by systematic review and meta-analysis.This file is created to capture 1 cases of pancreatitis.Please note, due to limited information provided in this literature, we cannot confirm of the echo devices used, which of the following caused the pancreatitis , the following is a list of potential rpn¿s: fnb: echo-hd-22-ebus-o - c / echo-hd-25-ebus-o - c or echo-hd-22-c / echo-hd-25-c or fna: echo-hd-22-ebus-o / echo-hd-25-ebus-o or echo-1-22 / echo-25.As per 'medical device reporting for manufacturer's (2016), section 4.16.2 'submit an individual report for each device identified if the generic names of the devices are different.' therefore, one report will be submitted in relation to the above serious injury.
 
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Type of Device
FCG KIT, NEEDLE, BIOPSY
Manufacturer (Section D)
COOK IRELAND LTD
o halloran road
limerick
MDR Report Key9931400
MDR Text Key196946216
Report Number3001845648-2020-00230
Device Sequence Number1
Product Code FCG
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type literature
Type of Report Initial,Followup
Report Date 05/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/06/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberUNKNOWN
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date06/28/2016
Event Location Hospital
Date Manufacturer Received04/01/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
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