BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETHICON END SURGICAL TROCAR 10/12MM BLUNT TIP

    MDR report key: 2771697 · Received September 25, 2012

    Report

    Report Number
    MW5027119
    Event Type
    Malfunction
    Date Received
    September 25, 2012
    Date of Event
    July 26, 2012
    Report Date
    September 25, 2012
    Manufacturer
    ETHICON ENDO-SURGERY, LLC, CUSTOMER SERVICE CENTER
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    RI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THIS PT WAS UNDER GOING LAPAROSCOPIC REPAIR OF AN INCARCERATED INCISIONAL HERNIA ALONG WITH LYSIS OF ADHESIONS. THE HUSSAN TROCAR WAS SECURED AT THE RIGHT FLANK AREA. IT BROKE APART AT THE SUTURE NOTCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHICON END SURGICAL TROCAR 10/12MM BLUNT TIP ENDOPATH BLUNT TIP OBTURATOR GCJ ETHICON ENDO-SURGERY, LLC, CUSTOMER SERVICE CENTER 512BA H44HSE

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR