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

Model Number	DSC-22-01
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Radiation Exposure, Unintended (3164)
Date of Event	01/04/2019
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.

• 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: 8639307
• Report Number: 3004904811-2019-00019
• Device Sequence Number: 16557970
• Product Code: FCG
• UDI-Device Identifier: 00855208005087
• UDI-Public: 00855208005087
• 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): 05/24/2019

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: DSC-22-01
• Device Catalogue Number: DSC-22-01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/03/2019
• Initial Report FDA Received Date: 05/24/2019
• 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: Required Intervention
• Patient Age: 51 YR