BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYNECARE TVT OBTURATOR SYSTEM

    MDR report key: 6597712 · Received May 30, 2017

    Report

    Report Number
    2210968-2017-03845
    Event Type
    Malfunction
    Date Received
    May 30, 2017
    Report Date
    January 24, 2017
    Manufacturer
    ETHICON SARL
    Product Code
    OTN
    PMA / PMN Number
    K033568
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE MANUFACTURING CRITERIA WERE MET PRIOR TO THE RELEASE OF THIS LOT. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: A UROLOGICAL PROCEDURE WAS PERFORMED. CAN YOU INDICATE WHAT WAS THE ACTUAL NAME OF PROCEDURE FOR EXAMPLE SLING? - IT WAS A PROCEDURE TO CORRECT AN URINARY INCONTINENCE WITH SLING. IT WAS REPORTED THAT THE DEVICE FAILED. PLEASE EXPLAIN HOW THE DEVICE FAILED FOR EXAMPLE DID THE MESH TEAR, WAS THERE DAMAGE TO THE WHITE PLASTIC SHEATH IF SO WHAT? - THE SURGEON REPORTED THAT ONCE SHE PASSED THE TVT SHE REALIZED THAT THE MESH WAS FRAYING AND UNRAVELING IN THE MESH EDGE (PICTURE) HOW WAS THE PROCEDURE COMPLETED? -THE SURGEON USED ANOTHER J&J TVTO 810081. CONFIRM NO PATIENT CONSEQUENCES AND CONFIRM DEVICE DISPOSED OF?.- THERE WAS NO PATIENT CONSEQUENCE AND THE DEVICE WAS DISCARDED NO CONCLUSION CAN BE DONE FOR THIS COMPLAINT. NO PRODUCT WAS RECEIVED FOR EVALUATION. AN INVESTIGATION WAS PERFORMED BASED ON THE BATCH RECORDS AND ON PICTURES. BASED ON THE EVALUATION, THIS COMPLAINT IS NOT LINKED TO A MANUFACTURING ISSUE. THE DEFECT SEEN DURING THE EVALUATION (MESH STRETCHED, FRAYED) IS ALIGNED WITH THE DELAMINATION OR FRAYING NEVERTHELESS BECAUSE THE PRODUCT HAS NOT BEEN SENT FOR EVALUATION, NO CONCLUSION CAN BE DONE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SLING PROCEDURE FOR URINARY INCONTINENCE ON UNKNOWN DATE AND THE MESH WAS IMPLANTED. DURING THE PROCEDURE, ONCE THE SURGEON PASSED THE MESH, IT WAS NOTICED THAT THE MESH WAS FRAYING AND UNRAVELING IN THE MESH EDGE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378635 GYNECARE TVT OBTURATOR SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON SARL UNK 3904068

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR