BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JAWS NITINOL STAPLE SYSTEM

    MDR report key: 13043761 · Received December 20, 2021

    Report

    Report Number
    3008650117-2021-00140
    Event Type
    Injury
    Date Received
    December 20, 2021
    Date of Event
    November 23, 2021
    Report Date
    December 20, 2021
    Manufacturer
    PARAGON 28, INC
    Product Code
    JDR
    PMA / PMN Number
    K170923
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REPORT 1 (STAPLE) OF 2.

    Description of Event or Problem · 0

    DIFFICULTY WITH THE JAWS STAPLE RELEASING FROM THE INSERTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1941622 JAWS NITINOL STAPLE SYSTEM STRAIGHT STAPLE ASSEMBLY, 18 X 18MM JDR PARAGON 28, INC P71-018-1818-S 26031762104

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Unknown Other