BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 8719513 · Received June 20, 2019

    Report

    Report Number
    2210968-2019-83074
    Event Type
    Injury
    Date Received
    June 20, 2019
    Report Date
    May 27, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS RELATED TO A JOURNAL ARTICLE, THEREFORE NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. NO SPECIFIC PATIENT INFORMATION REGARDING EVENTS HAS BEEN PROVIDED. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: DIS COLON RECTUM 2006; 49: 652¿660; DOI: 10.1007/S10350-006-0505-6. SEE REFERENCED ARTICLE - (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE "TITLE : IMPACT OF NEW TECHNOLOGIES ON THE CLINICAL AND FUNCTIONAL OUTCOME OF ALTEMEIER¿S PROCEDURE: A RANDOMIZED, CONTROLLED TRIAL. " AUTHOR : PAOLO BOCCASANTA, M.D.,1 MARCO VENTURI, M.D.,1 SERGIO BARBIERI, M.D.,2 GIANCARLO ROVIARO, M.D. CITATION: DIS COLON RECTUM 2006; 49: 652¿660; DOI: 10.1007/S10350-006-0505-6. THIS RANDOMIZED STUDY WAS PERFORMED TO ASSESS WHETHER THE ASSOCIATION OF HARMONIC SCALPEL AND CIRCULAR STAPLER OFFER ADVANTAGES OVER THE CONVENTIONAL TECHNIQUE ON THE CLINICAL AND FUNCTIONAL OUTCOME OF SELECTED PATIENTS WITH FULL-THICKNESS RECTAL PROLAPSE AND FECAL INCONTINENCE, SUBMITTED TO PERINEAL RECTOSIGMOIDECTOMY (ALTEMEIER¿S OPERATION) WITH LEVATORPLASTY. FROM JAN1999 TO DEC2003, 40 PATIENTS WITH FULL-THICKNESS RECTAL PROLAPSE UNDERWENT EITHER CONVENTIONAL PERINEAL RECTOSIGMOIDECTOMY WITH PERINEAL LEVATORPLASTY, USING ELECTROCAUTERY WITH HANDSEWN COLOANAL ANASTOMOSIS (N=20; N=19 FEMALE; MEAN AGE OF 72.4±10.4 YEARS) OR ALTEMEIER¿S PROCEDURE WITH HARMONIC SCALPEL FOR TISSUE DISSECTION AND STAPLED COLOANAL ANASTOMOSIS (N=20; N=18 FEMALE; MEAN 71.5±12.2 YEARS). IN CONVENTIONAL GROUP, THE UPPERMOST VISIBLE PERITONEUM WAS SUTURE WITH VICRYL 2-0. ANTERIOR AND POSTERIOR LEVATORPLASTY WERE PERFORMED BY USING SEPARATE STITCHES OF PROLENE 2-0 TO CLOSE THE DIASTASIS OF LEVATOR ANI AND REINFORCE THE PELVIC FLOOR. HANDSEWN COLOANAL ANASTOMOSIS WITH INTERRUPTED 3.0 VICRYL SUTURES WAS PERFORMED BETWEEN THE UPPER COLON AND THE DIVIDED ANAL RING. IN STAPLED ALTEMEIER GROUP, ULTRACISION HARMONIC SCALPEL G300 AND COAGULATING SHEARS 14C FOR TISSUE DISSECTION WITHOUT VESSEL LIGATURES. FOR COLOANAL ANASTOMOSIS, PPH-01 CIRCULAR STAPLER, ETHICON WAS USED. TWO PURSE-STRINGS WITH PROLENE 2-0 WERE USED IN THE FULL-THICKNESS WALL OF THE COLON STUMP AND IN THE DIVIDED RESIDUAL ANAL RING STUMP, ABOVE THE DENTATE LINE. HEMOSTATIC STITCHES WITH VICRYL 3-0 WERE OCCASIONALLY REQUIRED. POSTOPERATIVELY, COMPLICATIONS INCLUDED STENOSIS (N=2 CONVENTIONAL ALTEMEIER¿S GROUP) TREATED WITH TRANSANAL DILATATIONS. PAIN WAS OBSERVED AT POSTOPERATIVE DAY 1 (N=? [MEAN SD OF 2.6±0.4] CONVENTIONAL ALTEMEIER¿S GROUP; N=? [MEAN SD OF 2.5±0.3] STAPLED ALTEMEIER¿S GROUP); AT POSTOPERATIVE DAY 2 (N=? [MEAN SD OF 2.5±0.4] CONVENTIONAL ALTEMEIER¿S GROUP; N=? [MEAN SD OF 2.6±0.4] STAPLED ALTEMEIER¿S GROUP; AT POSTOPERATIVE DAY 3 (N=? [MEAN SD OF 2.4±0.3] CONVENTIONAL ALTEMEIER¿S GROUP; N=? [MEAN SD OF 2.3±0.3] STAPLED ALTEMEIER¿S GROUP; AT POSTOPERATIVE DAY 4 (N=? [MEAN SD OF 1.9±0.3] CONVENTIONAL ALTEMEIER¿S GROUP; N=? [MEAN SD OF 1.8±0.2] STAPLED ALTEMEIER¿S GROUP; AT POSTOPERATIVE DAY 5 (N=? [MEAN SD OF 1.7±0.3] CONVENTIONAL ALTEMEIER¿S GROUP; N=? [MEAN SD OF 1.6±0.2] STAPLED ALTEMEIER¿S GROUP; AT POSTOPERATIVE DAY 6 (N=? [MEAN SD OF 1±0.2] CONVENTIONAL ALTEMEIER¿S GROUP; N=? [MEAN SD OF 1±0.2] STAPLED ALTEMEIER¿S GROUP; AND AT POSTOPERATIVE DAY 7 (N=? [MEAN SD OF 0.9±0.2] CONVENTIONAL ALTEMEIER¿S GROUP; N=? [MEAN SD OF 0.8±0.2] STAPLED ALTEMEIER¿S GROUP. THE CLINICAL AND FUNCTIONAL LONG-TERM RESULTS OF PERINEAL RECTOSIGMOIDECTOMY WITH LEVATORPLASTY ARE NOT INFLUENCED BY SURGICAL INSTRUMENTS AND TYPE OF COLOANAL ANASTOMOSIS. THE USE OF HARMONIC SCALPEL AND CIRCULAR STAPLER IS ASSOCIATED WITH LESS BLOOD LOSS DURING THE OPERATION, SHORTER OPERATIVE TIME, AND HOSPITAL STAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    510338 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention