BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYNECARE TVT OBTURATOR SYSTEM

    MDR report key: 6388410 · Received March 8, 2017

    Report

    Report Number
    2210968-2017-01786
    Event Type
    Malfunction
    Date Received
    March 8, 2017
    Date of Event
    January 9, 2017
    Report Date
    January 10, 2017
    Manufacturer
    ETHICON SARL
    Product Code
    OTN
    PMA / PMN Number
    K033568
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    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. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: IT WAS REPORTED THE PRODUCT DISARMS, LOSS OF MESH PROPERTIES. PLEASE EXPLAIN WHAT YOU ARE REFERRING TO, DO YOU MEAN ONE OF THE FOLLOWING, PLEASE EXPLAIN: DID THE MESH DETACH FROM THE POSITIONING LINES? - THE MESH BREAKS DOWN AT THE MOMENT OF TOUCHING IT. DID THE POSITIONING LINES DETACH FROM THE WHITE TROCAR THAT COVERS THE HELICAL PASSER? -THE ISSUE IS REFERRED TO THE STIFFNESS OF THE MESH. IT WAS NOT REPORTED IF THE DEVICE WAS AVAILABLE FOR RETURN PLEASE ADVISE? THE DEVICE WILL BE RETURNED. WAS THE STERILITY COMPROMISED? NO, IT WAS HANDLED AS THE INSTRUCTIONS INDICATED. WAS THE PACKAGING NOT PROPERLY SEALED? NO, IT WAS HANDLED AS THE INSTRUCTIONS INDICATED. WAS THE PRODUCT RECEIVED WITH THE COVER DAMAGED OUT? NO, THE BOX WAS IN GOOD CONDITION. DID THE EVENT OCCUR WHEN THE PRODUCT WAS BEING OPENED? NO, THE EVENT OCCURRED DURING ITS USE. WAS THERE DIFFICULTY OPENING THE PRODUCT? NO, THE PROCEDURE AND THE OPENING OF THE PRODUCT DIDN´T HAVE ANY INCONVENIENCES. YOU INDICATED THAT THE MESH WOULD BE RETURNED, IS THE PACKAGING GOING TO ACCOMPANY THE DEVICE? NO, NOT THE BOX. THE HOSPITAL THREW IT AWAY.

    Additional Manufacturer Narrative · 1

    PARTS OF ONE DEVICE OF LOT #3919242, PRODUCT CODE 810081 WAS RECEIVED WITH 2 PLASTIC NEEDLES , 2 HELICAL GUIDES, THE MESH CUT, A PART OF PLASTIC SHEATH. THE DEVICE RECEIVED WAS MANIPULATED AND USED. THE MESH WAS DETACHED FROM THE PLASTIC NEEDLES AND CUT. THE MESH WAS FRAYED, DAMAGED. THE DEFECT WAS NOT LINKED TO A MANUFACTURING ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2017 AND THE MESH WAS IMPLANTED. DURING THE PROCEDURE, THE MESH BROKE DOWN AT THE MOMENT OF TOUCHING IT. IT WAS ALSO REPORTED THAT THE ISSUE WAS REFERRED TO THE STIFFNESS OF THE MESH. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171276 GYNECARE TVT OBTURATOR SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON SARL UNK 3919242

    Patients

    Seq Age Sex Outcome Treatment
    1