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 Code	Abdominal Pain (1685)
Date of Event	06/08/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Title: randomized controlled trial comparing the franseen needle with a fork-tip needle for eus-guided fine-needle biopsy source: american society for gastrointestinal endoscopy | published date: 25 may 2020.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to literature source of study performed (may 2020), post endoscopic ultrasound-guided fine needle biopsy, out of the 71 patients, there were 4 cases of abdominal pain with one patient seen in the emergency department and was discharged with a 2-day narcotic prescription, and the other three was managed with over the counter medications with no hospital visit.Article: munish ashat, md, 2020, 25 may.

• 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: 10471236
• Report Number: 3004904811-2020-00024
• Device Sequence Number: 19638038
• 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): 08/31/2020

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: 08/13/2020
• Initial Report FDA Received Date: 08/31/2020
• 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
• Patient Age: 64 YR