BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRI-STAPLE 2.0

    MDR report key: 11677657 · Received April 16, 2021

    Report

    Report Number
    11677657
    Event Type
    Malfunction
    Date Received
    April 16, 2021
    Date of Event
    February 10, 2021
    Report Date
    April 5, 2021
    Manufacturer
    COVIDIEN LP
    Product Code
    GDW
    UDI-DI
    10705036014607
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 0

    AFTER INSERTING RELOAD, THE COVIDIEN LP TRI-STAPLE 2.0 SURGICAL STAPLE LOADING UNIT COULD NOT BE TESTED BECAUSE IT WOULD NOT ENGAGE. A NEW RELOAD WAS INSERTED WITH THE SAME RESULTS. A NEW TRI-STAPLE 2.0 SURGICAL STAPLE LOADING UNIT WAS THEN OPENED, AND USED WITHOUT ANY FURTHER ISSUES.

    Description of Event or Problem · 0

    AFTER INSERTING RELOAD, THE COVIDIEN LP TRI-STAPLE 2.0 SURGICAL STAPLE LOADING UNIT COULD NOT BE TESTED BECAUSE IT WOULD NOT ENGAGE. A NEW RELOAD WAS INSERTED WITH THE SAME RESULTS. A NEW TRI-STAPLE 2.0 SURGICAL STAPLE LOADING UNIT WAS THEN OPENED, AND USED WITHOUT ANY FURTHER ISSUES.

    Description of Event or Problem · 1

    AFTER INSERTING THE SURGICAL STAPLES RELOAD, THE ETHICON ENDO-SURGERY ECHELON FLEX POWERED PLUS ARTICULATING ENDOSCOPIC LINEAR CUTTER (STAPLER) COULD NOT BE TESTED BECAUSE IT WOULD NOT ENGAGE. A NEW RELOAD WAS INSERTED WITH THE SAME RESULTS. A NEW ETHICON ENDO-SURGERY ECHELON FLEX POWERED PLUS ARTICULATING ENDOSCOPIC LINEAR CUTTER WAS THEN OPENED, AND USED WITHOUT ANY FURTHER ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    574055 TRI-STAPLE 2.0 STAPLE, IMPLANTABLE GDW COVIDIEN LP SIGTRSB60AMT N0K0321Y 10705036014607

    Patients

    Seq Age Sex Outcome Treatment
    1 29930 DA