BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHICON ENDO-SURGERY, INC. ETHICON FLEXIPATH

    MDR report key: 11677916 · Received April 15, 2021

    Report

    Report Number
    MW5100813
    Event Type
    Injury
    Date Received
    April 15, 2021
    Date of Event
    April 9, 2021
    Report Date
    April 14, 2021
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GCJ
    UDI-DI
    10705036011910
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ETHICON 15 MM FLEXIBLE TROCAR REF FP015 INSERTED INTO THE PATIENT. SHORTLY AFTER IT WAS NOTED THAT THE TROCAR'S INTEGRITY HAD BECOME COMPROMISED SO IT WAS REMOVED AND A NEW TROCAR INSERTED. A PIECE OF THIS SECOND TROCAR BROKE OFF IN THE PATIENT AND WAS RETRIEVED. BOTH WITH SAME LOT NUMBERS. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568266 ETHICON ENDO-SURGERY, INC. ETHICON FLEXIPATH LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ ETHICON ENDO-SURGERY, INC. FP015 U05J1C 10705036011910
    568267 ETHICON FLEXIPATH LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ ETHICON ENDO-SURGERY, INC. FP015 U05J1C

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention