• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN LP BARRX SHARKCORE KIT, NEEDLE, BIOPSY

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

COVIDIEN LP BARRX SHARKCORE KIT, NEEDLE, BIOPSY Back to Search Results
Model Number DSL-19-01
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abdominal Pain (1685); Radiation Exposure, Unintended (3164)
Event Date 06/03/2020
Event Type  Injury  
Manufacturer Narrative
Title: comparison of two specialized histology needles for endoscopic ultrasound (eus)-guided liver biopsy: a pilot study source: digestive diseases and sciences https://doi. Org/10. 1007/s10620-020-06391-3, received: 22 april 2020 / accepted: 3 june 2020 springer science+business media, llc, part of springer nature 2020. If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the literature source of the study performed, from october, 2018 to september 2019. Two of the patients form the same study had a biopsy using the competitors and company's device. Both patients reported an abdominal pain after the operation and had a ct-scan, which showed no abnormal finding. The patients stayed overnight for observation and were discharged the next morning after their pain was controlled by medication.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSHARKCORE
Type of DeviceKIT, NEEDLE, BIOPSY
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 Key10488532
MDR Text Key205737079
Report Number3004904811-2020-00025
Device Sequence Number1
Product Code FCG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K141894
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,literatur
Reporter Occupation
Type of Report Initial
Report Date 09/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/03/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberDSL-19-01
Device Catalogue NumberDSL-19-01
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/17/2020
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: 09/03/2020 Patient Sequence Number: 1
-
-