BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 1170348 · Received September 11, 2008

    Report

    Report Number
    2210968-2008-00810
    Event Type
    Malfunction
    Date Received
    September 11, 2008
    Report Date
    August 12, 2008
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K033568
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: 09/11/2008. PLASTIC TUBE DAMAGE/BREAKAGE. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A SLING PROCEDURE ON AN UNKNOWN DATE. DURING PLACEMENT OF THE SLING, THE SURGEON EXPERIENCED UNPRECEDENTED RESISTANCE ON THE PATIENT'S LEFT SIDE, WHILE THE PLASTIC-COVERED TROCAR WAS GUIDED FROM THE OBTURATOR FORAMEN OUT THROUGH THE SKIN INCISION. APPLYING STRONGER THAN THE USUAL FORCE ONTO THE TROCAR, THE PROCEDURE SUCCEEDED WITHOUT CAUSING ANY DAMAGE TO THE PATIENT. HOWEVER, WHEN THE INSTRUMENT WAS PASSED OUT THROUGH THE EXTERNAL SKIN INCISION, THE SHARP, CUTTING-EDGE PLASTIC-SHEATH WAS FOUND TO HAVE LOOSENED AND IT END BENT 180 DEGREES AWAY FROM IT'S INTENDED DIRECTION. THE PROCEDURE WAS OTHERWISE TOTALLY UNCOMPLICATED AND, THE SURGEON OPINES THAT HE USED NO INAPPROPRIATE FORCE OR MANIPULATION ON THE INSTRUMENTS TO JUSTIFY PREMATURE DISENGAGEMENT OF THE PLASTIC SHEATH. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE SAME DEVICE WITH NO ADVERSE PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK