BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHARKCORE

    MDR report key: 23510364 · Received November 10, 2025

    Report

    Report Number
    3004904811-2025-00049
    Event Type
    Injury
    Date Received
    November 10, 2025
    Date of Event
    April 9, 2025
    Report Date
    November 10, 2025
    Manufacturer
    COVIDIEN LLC
    Product Code
    FCG
    PMA / PMN Number
    K141894
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    HISTOLOGIC DIAGNOSIS OF PANCREATIC CYSTIC LESIONS WITH ENDOSCOPIC ULTRASOUND FINE NEEDLE BIOPSY AND IMPACT ON MANAGEMENT DECISIONS / ANKIT MISHRA, THOMAS M. HUNOLD, DHIRAJ K. PEDDU, GEORGE M. PHILIPS, ERIK-JAN WAMSTEKER, RICHARD S. KWON, ALLISON R. SCHULMAN, JIAQI SHI, EILEEN S. CARPENTER, AND JORGE D. MACHICADO. / DIGESTIVE DISEASES AND SCIENCES (2025) 70:2873¿2881 / YEAR OF PUBLICATION: : 22 APRIL 2025 / HTTPS://DOI.ORG/10.1007/S10620-025-09056-1 MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED ON THE LITERATURE THAT A RETROSPECTIVE STUDY EVALUATED ENDOSCOPIC ULTRASOUND WITH FINE NEEDLE BIOPSY FOR OBTAINING A DIAGNOSIS OF PANCREATIC CYSTIC LESIONS BETWEEN MARCH 2016 AND FEBRUARY 2024. THERE WERE 100 PATIENTS IN THE STUDY AND THE BIOPSY WAS PERFORMED WITH THE NEEDLE IN 90% PATIENTS. POSTOPERATIVE COMPLICATIONS INCLUDED MILD PANCREATITIS IN FOUR PATIENTS WHICH WAS NOT DIRECTLY RELATED TO THE NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2525421 SHARKCORE BIOPSY NEEDLE FCG COVIDIEN LLC DSC-22-01

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Other