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U.S. Department of Health and Human Services

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

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COVIDIEN LP BARRX SHARKCORE KIT, NEEDLE, BIOPSY Back to Search Results
Model Number DSC-22-01
Device Problem Insufficient Information (3190)
Patient Problems Pain (1994); Radiation Exposure, Unintended (3164)
Event Date 01/04/2019
Event Type  Injury  
Manufacturer Narrative
Title endoscopic ultrasound-guided biopsy in chronic liver disease: a randomized comparison of 19-g fna and 22-g fnb needles source endoscopic ultrasound-guided biopsy endoscopy international open, volume 07, 2019 (e62-71) date of publication: 6 november 2018. If information is provided in the future, a supplemental report will be issued. (b)(4).
 
Event Description
According to the literature source of study performed 2018, the patient underwent initial esophageal upper sphincter guided liver biopsy using to different needles. The patient experienced pain after the procedure but was discharged without pain. After one day of the procedure. During a follow-up call, the patient reports pain and was instructed to go to the emergency department. The laboratory testing showed stable hemoglobin and the ct scan showed no visible hemorrhage, perforation or abscess. The patient was sent home and did not report pain during the 7 day follow-up call.
 
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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 Key8639307
MDR Text Key146049653
Report Number3004904811-2019-00019
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 05/24/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/24/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberDSC-22-01
Device Catalogue NumberDSC-22-01
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 Received05/03/2019
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: 05/24/2019 Patient Sequence Number: 1
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