BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE - OBTURATOR UNKNOWN PROD

    MDR report key: 7683257 · Received July 12, 2018

    Report

    Report Number
    2210968-2018-74312
    Event Type
    Injury
    Date Received
    July 12, 2018
    Report Date
    June 28, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K033568
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CITATION: THE AMERICAN JOURNAL OF SURGERY. 2010; 199: 144¿153. DOI: 10.1016/J.AMJSURG.2008.11.040. [(B)(4)].

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: PROSPECTIVE CLINICAL AND FUNCTIONAL RESULTS OF COMBINED RECTAL AND UROGYNECOLOGIC SURGERY IN COMPLEX PELVIC FLOOR DISORDERS" AUTHOR : PAOLO BOCCASANTA, M.D.A,*, MARCO VENTURI, M.D.A, MAURIZIO SPENNACCHIO, M.D.A, ARTURO BUONAGUIDI, M.D.B, ANGELO AIROLDI, M.D.A, GIANCARLO ROVIARO, M.D CITATION: THE AMERICAN JOURNAL OF SURGERY. 2010; 199: 144¿153. DOI: 10.1016/J.AMJSURG.2008.11.040. THE AIM OF THIS PROSPECTIVE STUDY WAS TO EVALUATE THE RESULTS OF COMBINED RECTAL AND UROGYNECOLOGIC SURGERY IN WOMEN WITH ASSOCIATED OBSTRUCTED DEFECATION, URINARY INCONTINENCE, OR GENITAL PROLAPSE. A TOTAL OF 142 SELECTED PATIENTS WITH OBSTRUCTED DEFECATION SYNDROME (ODS) IN ISOLATION OR ASSOCIATED WITH STRESS URINARY INCONTINENCE (SUI), ENTEROCELE, OR GENITAL PROLAPSE WERE CONSECUTIVELY OPERATED ON BY STAPLED TRANSANAL RECTAL RESECTION ALONE OR ASSOCIATED WITH TRANSOBTURATOR TAPE, VAGINAL REPAIR OF THE ENTEROCELE, OR VAGINAL HYSTERECTOMY, RESPECTIVELY, AND FOLLOWED UP BY CLINICAL CONTROLS AND DEFECOGRAPHY. OF WHICH, 74 PATIENTS (MEAN AGE, 68.9 ± 5.5 YEARS; BMI: 25.6 ± 2.3) WERE SUBMITTED TO THE DOUBLE STAPLED TRANSANAL RECTAL RESECTION (STARR) PROCEDURE AND 68 PATIENTS (MEAN AGE, 68.5 ± 4.7 YEARS; BMI: 26.1 ± 2.5) UNDERWENT STARR PLUS CONCOMITANT PELVIC FLOOR SURGERY. IN THE STARR PROCEDURE, THE ORIGINAL TECHNIQUE WAS PERFORMED USING PPH-01TM KITS (ETHICON). IN THE TRANSOBTURATOR TAPE (TVT-O) PROCEDURE, THE TECHNIQUE WAS PERFORMED USING GYNECARE TVT OBTURATOR SYSTEM (ETHICON). IN THE VAGINAL REPAIR OF ENTEROCELE (VARE), THE AUTHORS DID MOSCHOWITZ PROCEDURE BY EXCISING THE EXCESS PERITONEUM, AND THEN WE REPAIRED THE VAGINAL VAULT BY THE FIXATION OF THE VAGINAL APEX TO THE SACROSPINOUS RIGHT LIGAMENT, USING PROLENE 0 NON-ABSORBABLE PURSE-STRING SUTURE. DURING VAGINAL HYSTERECTOMY (VAHY), THE PROCEDURE WAS PERFORMED USING VICRYL 2-0 ABSORBABLE STITCHES. IN THE STARR GROUP, REPORTED COMPLICATIONS INCLUDED BLEEDING (N-3), RECTAL STENOSIS (N-1) WHICH WAS SUCCESSFULLY SUBMITTED TO REPEATED ANAL DILATIONS WITH HEGAR DILATORS, AND FECAL URGENCY (N-15) WHICH REQUIRED TREATMENT WITH PREGABALIN IN 2 PATIENTS. IN THE STARR PLUS CONCOMITANT PELVIC FLOOR SURGERY, REPORTED COMPLICATION INCLUDED BLEEDING (N-3) AND FECAL URGENCY (N-13). IN THE STARR PLUS VAHY GROUP, REPORTED COMPLICATIONS INCLUDED LESION OF THE VAGINA WHICH WAS CAUSED BY ENTRAPPING THE VAGINAL WALL IN THE STAPLER DEVICE DURING THE ANTERIOR TIME OF STARR (N-1), WHICH WAS DIRECTLY REPAIRED WITH A SERIES OF VICRYL 3-0 ABSORBABLE STITCHES WITH NO AFTEREFFECTS, LESION OF THE SMALL INTESTINE LEADING TO PERITONITIS (N-1), WHICH REQUIRED LAPAROTOMY, WITH THE REPAIR OF THE LESION USING VICRYL 3-0 ABSORBABLE STITCHES WITH NO AFTEREFFECTS, AND RESIDUAL STAGE II ASYMPTOMATIC PROLAPSE OF THE ANTERIOR VAGINAL SEGMENT (N-2) WITHOUT ANY RE-OPERATIONS DONE. IN THE STARR PLUS TVT-O GROUP, REPORTED COMPLICATION INCLUDED VOIDING DIFFICULTIES WITH RECURRENT URINARY TRACT INFECTION (N-3). IT WAS CONCLUDED THAT THE ASSOCIATION OF STARR AND UROGYNECOLOGIC OPERATIONS HAS EQUAL EFFECTIVENESS TO STARR ALONE. THE COMBINATION OF STARR AND VAHY INCREASES SHORT-TERM MORBIDITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    526114 TENSION FREE VAGINAL TAPE - OBTURATOR UNKNOWN PROD MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGICAL OTN ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention