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

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.

• Brand Name: SHARKCORE
• Type of Device: KIT, 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 Key: 10488532
• MDR Text Key: 205737079
• Report Number: 3004904811-2020-00025
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 00855208005131
• UDI-Public: 00855208005131
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141894
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• 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 Received: 09/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DSL-19-01
• Device Catalogue Number: DSL-19-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/17/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention