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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN LP BARRX UNKNOWN BEACON NEEDLE BIOPSY NEEDLE

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COVIDIEN LP BARRX UNKNOWN BEACON NEEDLE BIOPSY NEEDLE Back to Search Results
Model Number UNKNOWN BEACON NEEDLE
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Pancreatitis (4481)
Event Date 03/09/2022
Event Type  Injury  
Event Description
According to literature source of study performed 2017, a total of 60 lesions were sampled and 41 using a fine needle biopsy. One patient with fine needle biopsy of pancreatic or ampullary lesion developed mild acute pancreatitis.
 
Manufacturer Narrative
Title: retrospective evaluation of diagnostic yield for sharkcoretm and acquiretm fine needle biopsy (fnb) needles in endoscopic ultrasound (eus) guided sampling of solid lesions source: gastrointestinal endoscopy volume 85, no. 5s: 2017. Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803. This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda. Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report. This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report. In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿. These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting. Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms. This statement should be included with any information or report disclosed to the public under the freedom of information act. Any required fields that are unpopulated are blank because the information is currently unknown or unavailable. A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
 
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Brand NameUNKNOWN BEACON NEEDLE
Type of DeviceBIOPSY NEEDLE
Manufacturer (Section D)
COVIDIEN LP BARRX
covidien gi solutions
sunnyvale CA 94085 4022
Manufacturer (Section G)
COVIDIEN LP BARRX
covidien gi solutions
sunnyvale CA 94085 4022
Manufacturer Contact
amy beeman
161 cheshire lane, suite 100
plymouth, MN 55441
7632104064
MDR Report Key14108698
MDR Text Key294522295
Report Number3004904811-2022-00005
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
Report Date 04/13/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/13/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberUNKNOWN BEACON NEEDLE
Device Catalogue NumberUNKNOWN BEACON NEEDLE
Was Device Available for Evaluation? No
Date Manufacturer Received03/25/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/13/2022 Patient Sequence Number: 1
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