BEUDAMED
    FDA Adverse Event Other Summary report: N

    SURX

    MDR report key: 537275 · Received July 15, 2004

    Report

    Report Number
    537275
    Event Type
    Other
    Date Received
    July 15, 2004
    Date of Event
    January 29, 2004
    Report Date
    July 6, 2004
    Manufacturer
    COOPER SURGICAL, INC.
    Product Code
    GXD
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A PT WITH HISTORY OF SYMPTOMATIC UTERINE FIBROIDS AND URODYNAMIC STRESS INCONTINENCE. THE PT UNDERWENT A TOTAL VAGINAL HYSTERECTOMY, BILATERAL SALPINGO-OOPHORECTOMY, MCCALL'S CULDOPLASTY WITH CYSTOSCOPY AND SURX (RADIOFREQUENCY BLADDER NECK SUSPENSION, VAGINALLY). BLADDER FUNCTION HAD RETURNED AT FOLLOW-UP (F/U) APPOINTMENT SEVERAL DAYS LATER. THE PT REPORTED URINARY INCONTINENCE SEVERAL DAYS LATER AT THE CLINIC VISIT AND REPORTED AT THE SECOND CLINIC VISIT THAT HAD MORE INCONTINENCE THAN PRIOR TO SURGERY. A URETHROVAGINAL FISTULA WAS DIAGNOSED SEVERAL DAYS LATER, ~2 CM IN LENGTH, IN THE PROXIMAL TO MID THIRD OF THE URETHRA, MIDLINE, APPROXIMATING THE LENGTHS OF THE BILATERAL INCISIONS MADE IN THE VAGINA FOR THE SURX PROCEDURE. THE PT UNDERWENT A PRIMARY REPAIR OF THE URETHROVAGINAL FISTULA OF THE DISTAL URETHRA AND SUPRAPUBIC CATHETER PLACEMENT SEVERAL WEEKS LATER. A VOIDING CYSTOURETHROGRAM SEVERAL DAYS LATER REVEALED NO EVIDENCE OF FISTULOUS COMMUNICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURX RADIO FREQUENCY BLADDER NECK SUSPENSION GENERATOR GXD COOPER SURGICAL, INC. RFGEN2501 *
    2 * * --- * * *

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other DISPOSABLE TRANSVAGINAL RF APPLICATOR.