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

Model Number	DSL-19-01
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abdominal Pain (1685); Radiation Exposure, Unintended (3164)
Date of Event	06/03/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: KIT, NEEDLE, BIOPSY
• Manufacturer (Section D): COVIDIEN LP BARRX; covidien gi solutions; sunnyvale CA 94085 4022
• MDR Report Key: 10488532
• Report Number: 3004904811-2020-00025
• Device Sequence Number: 2889064
• Product Code: FCG
• UDI-Device Identifier: 00855208005131
• UDI-Public: 00855208005131
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K141894
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,literatur
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: DSL-19-01
• Device Catalogue Number: DSL-19-01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2020
• Initial Report FDA Received Date: 09/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention