BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH TRISTAR BLUNT TIP SURGICAL TROCAR

    MDR report key: 210039 · Received February 12, 1999

    Report

    Report Number
    1527736-1999-00761
    Event Type
    Malfunction
    Date Received
    February 12, 1999
    Date of Event
    January 19, 1999
    Report Date
    January 21, 1999
    Manufacturer
    ETHICON ENDO-SURGERY, INC. S.A. DE C.V.
    Product Code
    GCJ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICES WERE USED DURING A LAPAROSCOPIC CHOLECYSTECOTMY. IT WAS REPORTED BY THE REP THAT THE SURGEON PUT THE FIRST TWO TROCARS IN FROM THE KTI FTC11. EACH TIME HE REMOVED THE OBTURATOR THE SEALS OF THE TROCAR TORE. THEY PULLED INDIVIDUAL TROCARS TO FINISH THE CASE. THEY OPENED A SECOND FTC11 KIT AND THE 512S SEAL TORE ON IT WHEN THE OBTURATOR WAS REMOVED AS WELL. THERE WAS NO CONSEQUENCE TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH TRISTAR BLUNT TIP SURGICAL TROCAR TROCARS GCJ ETHICON ENDO-SURGERY, INC. S.A. DE C.V. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other