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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 Problems Abdominal Pain (1685); Abscess (1690); Fever (1858); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Sepsis (2067); Pancreatitis (4481)
Event Date 02/27/2022
Event Type  Injury  
Event Description
According to literature source of study performed from 2015 to 2020, a retrospective study of 723 patients were evaluated for the use of the a needle for pancreatic endoscopic ultrasound-guided fine needle biopsy procedures which consisted of 852 samples. One patient developed acute pancreatitis 3 hours after procedure and was discharged two days later, 28 patients had self-limiting local bleeding during the procedure, 17 patients complained of abdominal pain and were all discharged the same day as the procedure, 40 patients were admitted to a hospital within 7 days after the procedure and these were late complications and 10 patients had immediate complications average time admitted was 7. 9 days. One patient was admitted for 114 days, suffering from severe necrotic pancreatitis with abscess undergoing necrosectomy, and admission to the intensive care unit for a total of 40 days. One patient was hospitalized for 25 days with bleeding and underwent gastroduodenoscopy in general anesthesia, showing duodenal bleeding, most likely caused by the trans-duodenal endoscopic ultrasound-guided fine needle biopsy procedure and was treated by endoscopic therapy only and 2 patients needed intervention. 20 patients with acute pancreatitis, 13 patients complained who of abdominal pain, 2 patients with self-limiting bleeding, 1 patient with infection, 1 patient with sepsis and 1 patient with fever had been hospitalized for an average of 4. 6 days requiring only conservative treatment.
 
Manufacturer Narrative
Literature: title: accuracy and clinical outcomes of pancreatic eus-guided fine-needle biopsy in a consecutive series of 852 specimens. Source: doi: 10. 4103/eus-d-21-00180. 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 Key15067390
MDR Text Key296250937
Report Number3004904811-2022-00007
Device Sequence Number1
Product Code FCG
Combination Product (y/n)N
Reporter Country CodeDA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Literature,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 07/20/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/20/2022
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
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/06/2022
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: 07/20/2022 Patient Sequence Number: 1
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